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FDA针对一次性面罩再次发布EUA,将不再新增EUA厂家!

 

今天,美国FDA重新对进口的、非NIOSH批准的、在中国以外生产的一次性过滤面罩发布了Emergency Use Authorization (EUA)。FDA修订并重新发布了本EUA,以授权自重新发布之日起,仅紧急使用EUA 附录1中列出的呼吸器。从即日起,FDA将不再审查申请,也不再在EUA附件1中增加新的呼吸器型号。

同时附上目前最新的中国制造的授权进口、非NIOSH批准的呼吸器清单,以及从该清单中移除的呼吸器型号信息,供大家参考。

新闻原文如下:

FDA Reissues EUA for Certain Imported Disposable Filtering Facepiece Respirators

Today, the U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for imported, non-NIOSH-approved, disposable filtering facepiece respirators (FFRs)  manufactured in countries other than China. The FDA revised and reissued this EUA to authorize for emergency use only those respirators listed in the EUA’s Exhibit 1 as of the date of this reissuance. Effective immediately, the FDA will no longer be reviewing requests and adding new respirator models to Exhibit 1 of this EUA.

 

附录1详细见如下链接:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas?utm_medium=email&utm_source=govdelivery#imported

 

 

 

 

 

附录1 授权进口,非NIOSH一次性过滤面罩呼吸器(FFR)

(2021年3月24日重新发布)

 

SN

Manufacturer

Respirator Model(s)

Country of Manufacture

1

3M

8205

Japan

2

3M

8822

South Korea

3

3M

9320+

UK, Singapore, Turkey

4

3M

9322+

UK, Singapore, Turkey

5

Advanced Medical Devices Pty Limited

Nano-Tech P2 Particulate Respirator - T4

Australia

6

Allix Co., Ltd.

AM 200

South Korea

7

Alumitek Ingenieria S de RL de CV

MXN95R1

Mexico

8

Ap Mascarillas S.A. de C.V.

AP M10, AP Z6

Mexico

9

Best Pacific Vietnam Company Limited

MASK-VN-22

Vietnam

10

BioSerenity

1016-07003-US

France

11

Brands Unlimited S.A. de C.V.

Medimask MM-001, MM-002, MM-003 A, MM-003 B, MM-003 C, MM-003 D, MM-003 E, MM-003 F, MM-003 G, MM-003 H, MM-003 I, MM-003 J, MM-003 K, MM-003 L, MM-004 A, MM-004 B, MM-004 C, MM-004 D, MM-004 E, MM-004 F, MM-004 G, MM-004 H, MM-004 I, MM-004 J, MM-004 K, and MM-004 L

Mexico

12

BTL Industries

FLAT-FIT Healthcare Respirator

Bulgaria

13

Care Essentials Pty Ltd

MSK-001, MSK-001S, MSK-002, MSK-002S

Australia

14

Dromex

Model 1020

South Africa

15

Evolve Group Pty Ltd

IPKIS P2 Respirator

Australia

16

Galia Textil S.A. DE C.V

GTN95

Mexico

17

GCE Lighting / Savoy International

MRP-FFP2-AM-20

France

18

Grupo 10X SA DE CV d.b.a Sanitek Pro

Sanitek Pro N95

Mexico

19

Hwa Yui Co., Ltd

HY20

South Korea

20

Hygiene Austria LP GmbH

HA PP02

Austria

21

Keeo Life Private Limited

KF-SG-N95-HL, KF-SG-N95-EL

India

22

Lanaco Limited

WAIRE P2

New Zealand

23

Layfield Canada Ltd.

1970EU

Canada

24

Macopharma

F2001N

France

25

Manohar Filaments Private Limited

MF-SG-N95-HH, MF-SG-N95-EH

India

26

Mkteks Mensucat Tekstil Sanayi VE Ticaret Limited Sirketi

WV NR 101

Turkey

27

MUSK Medikal Tekstil Plastik Sanayi Ve Ticaret Limited Sirketi

MUSK001

Turkey

28

MY ARLET

ARLET 5000 FFP2 NR, ARLET 6000 FFP3 NR

Turkey

29

Novita, 9 Koi Marketing Pte Ltd

R5, R7

Singapore

30

NTI Vina Co. Ltd.

SG9010V

Vietnam

31

Plastcor Do Brasil LTDA

ECHO PFF2 CA 38.811

Brazil

32

Productos Químicos y Farmacéuticos R&M S.A de C.V.

PLB 95

Mexico

33

Rang Company

MB100

South Korea

34

Rose Personal Protective Equipment Industry and Trade Anonym Company

IRYS-08

Turkey

35

Softmed Manufacturing Pty Ltd

SM-RC201, SM-RF202

Australia

36

Sonata Calcetin S.A. de C.V.

CB01

Mexico

37

Tenamyd Pharmaceutical Corporation

Tenamyd FM-N95 Model YCKTC13, Tenafa® N-95 Model YCTFA04, Tenami® N-95 Model YCTM102, YCTFM02, YCTFA07, YCTMI08, YCTFM01, YCTFA06, YCTMI07

Vietnam

38

TRN MODA TEKSTIL SAN VE TIC LTD STI

O2BLS-NRFM002, O2BLS-NRFM003

Turkey

 

 

附录A:中国制造的授权进口、非NIOSH批准的呼吸器

(2021年2月18日更新)

 

SN

Manufacturer

Respirator Model(s)

Country of Manufacturer

1

3M

9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V

China

2

Allmed Medical Products Co., Ltd

LP220002

China

3

AnDum Protective Equipment Technology (Changzhou) Co.,Ltd.

AD-1001

China

4

Anhui Hanxiutang Biotechnology Co., Ltd.

HXT-01

China

5

ANHUI JIABAO PROTECTIVE EQUIPMENTS CO.,LTD

JB-RP001

China

6

Anhui Jinrui Auto Parts Co., Ltd.

JR-01

China

7

Anhui Zhongke Duling Commercial Appliance Co. Ltd

M-9501

China

8

Anshun Health and Medical Technology Co., Ltd.

AKF6002

China

9

AOK Tooling Ltd. (aka Shenzhonghai Medical)

20130040, 20130045A, 20180021, 20130038, 20190019, 910, 20190029

China

10

Baoding Yinhong Yuhe Medical Device Manufacturing Co., Ltd.

YH/KN95-1

China

11

Bei Bei Safety Co Ltd.

B702, B702V, B704, B704V

China

12

Beifa Anhui Manufacturing Co., Ltd.

BF-A-01

China

13

Beijing Topnew Import & Export Co., Ltd.

ZY95

China

14

BG PRECISION CO. LTD

KN95-N

China

15

BYD Precision Manufacture Co. Ltd.

DG3101, DN1102

China

16

Careable Biotechnology Co., Ltd.

CARE002, CARE003

China

17

Carte Medical Equipment (Suzhou) Co., Ltd

K8201

China

18

Changsha Changjiu Medical Technology Co. Ltd.

KN95-05, KN95-08

China

19

Changshu Dayi Health Protection Articles Co., Ltd

DY-3

China

20

Chengde Technology Co.

KN95

China

21

Chongqing China Nano Technology Co., Ltd.

ZN6005

China

22

Chongqing Zisun (Zaisheng) Technology Corp., Ltd.

ZS-ZD-FJ-1, ZS-ZD-WJ-1

China

23

Creative Concepts Manufacturing Ltd. aka Huizhou RD Plastic Co., Ltd

2676

China

24

Deli Group Co., LTD.

ET30000

China

25

DONGGUAN AOXING AUDIO VISUAL EQUIPMENT CO.,LTD

AX-KF95

China

26

Dongguan Arun Industrial Co., LTD

KN95 N9

China

27

Dongguan City Outdoorsy Co., Ltd.

OD-001

China

28

Dongguan Pan American Electronics Co., Ltd.

KN95-01, KN95-02, N1001

China

29

Dongguan Rysam Medical Equipment Manufacturing Co.

Particle Filtering half mask RSN95B, Particle Filtering half mask RSN99V

China

30

Dongguan Sengtor Plastics Products Co., Ltd.

KN95

China

31

Donghua Siecom Communication Technology Co.,Ltd

ZGKNM-01

China

32

ESound Medical Device Co., Ltd.

20182140615 Folded

China

33

FOSHAN FLOCON MEDICAL EQUIPMENTS CO., LTD

M1

China

34

Foshan Nanhai Chuanzhishang Clothing Co., LTD

CZ-S02

China

35

Fujian Dahong Industrial Development Co. Ltd.

PGT-0095

China

36

Fujian Leephick Pharmaceutical Industry Co. Ltd.

KPM-3

China

37

Fujian Yifa Healthcare Products Co., Ltd.

Y195

China

38

Fujian Yongtai Sanlian Garment Co., Ltd.

N95 Particulate Respirator (Xier)

China

39

Fuzhou Chunlan Medical Equipment Co., Ltd.

CL-P1

China

40

Guangdong GangRong Medical Technology Co., Ltd

GR200

China

41

GUANGDONG GOLDEN LEAVES TECHNOLOGY DEVELOPMENT CO., LTD.

8862 KN95

China

42

GUANGDONG JINGCOS CO., LTD

95J1

China

43

Guangdong KINGFA SCI. & TECH. Co. Ltd.

KF-A F01, KF-A F10(SC)

China

44

Guangdong Languan Medical Biotechnology Co., Ltd.

LGKN95

China

45

Guangdong Nuokang Medical Technology Co., Ltd.

KN95 Non-Surgical Disposable Particulate FFR

China

46

Guangdong Seyouse Technology and Culture CO,.LTD

SS-001

China

47

Guangdong Tengrui Pharmaceutical Technology Co., Ltd.

LSH-201

China

48

Guangdong Willing Technology Corporation

WL-01

China

49

Guangdong Winsun Personal Care Products Co., Ltd.

YS0003

China

50

Guangdong Yidao Medical

YD-002

China

51

Guangdong Zhizhen Biological Medicine Co., Ltd.

KN95 Three-Dimensional Protective Face Mask

China

52

Guangxi MC Medical equipment Co., Ltd​

MC010501

China

53

GUANGZHOU BIOFIL AIR PURIFICATION MATERIALS CO.,LTD

MY3D2

China

54

Guangzhou Bofeite Safety Protective Supplies Co., Ltd.

HT9510V, HT9510

China

55

Guangzhou Carrot Mall Network Technologies Co., Ltd.

IRYS-01

China

56

Guangzhou Harley Commodity Company Limited

L-103V KN95

China

57

Guangzhou Nan Qi Xing Non-Woven Co., Ltd.

KN-1 Respirator

China

58

Guangzhou Powecom Labor Insurance Supplies Co., LTD

KN95

China

59

Guanyang Yunhan Textile Co., Ltd.

YH-9500

China

60

Haishi Hainuo Lexiang Medical Technology (Qingdao) Co., Ltd.

LX1001

China

61

HANGZHOU FILTECH INTELLIGENT CO., LTD.

Filtech Face Mask Model F860, F862, F890V, F891V, F890, F861

China

62

Hangzhou Gang Yu Health Products Co., Ltd.

GY2020001

China

63

Hangzhou San Qiang Safety Protection Products Co., Ltd.

9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9450B, 9480V (FFP2), 9980V (FFP3), 9920V (FFP3)

China

64

Hebei Pengyuan Optoelectronics Co., Ltd.

SUPERNOVA-P2

China

65

Henan Aklly Filter Engineering Co., Ltd.

KZ888E

China

66

Henan Bingzun Industrial Co.,Ltd.

8410

China

67

Henan Yadu Industrial Co., Ltd

Flat Fold

China

68

Heyuan COE Communication Technology Co., Ltd.

CHMM-NB

China

69

Hubei Huaqiang High-Tech Co., Ltd.

Flat Fold (Earloop) Non-Sterile

China

70

Hui Zhou Tian Chang Industrial Co., Ltd.

N002-AW

China

71

Huizhou Green Communication Equipment Manufacturing Co., Ltd

​G95200 Particle Filtering Half Mask

China

72

Huizhou Huinuo Technology Co., Ltd

9501A

China

73

Huizhou Yibaidu Medical Device Technology Co., Ltd.

YBD-2

China

74

Hunan Boltpower Guokang Medical Equipment Co., Ltd.

GK-002A

China

75

Hunan Changyuan Technology Co., Ltd.

CY005 Filtering Half Mask

China

76

Hunan EEXI Technology & Service Co., Ltd.

YX152, YX153

China

77

Hunan Hengchang Pharmaceutical Co., LTD.

N9501-L (non-sterile type)

China

78

Hunan Jianyuan Medical Science and Technology Co. Ltd.

JY009A

China

79

Hunan Kangweining Medical Devices Co., Ltd.

YH-I (non-sterile) and YH-II (sterile)

China

80

Jiande Chaomei Daily Chemicals Co.

F-Y3-A

China

81

Jiangmen Nostop Electric Co., Ltd

JW-017

China

82

JIANGSU CHANGMEI MEDTECH CO.,LTD

DFM-01

China

83

JiangSu EverSmart Nano Technology Co., Ltd.

HZ-KN95

China

84

JIANGSU HOMCAN MEDICAL TECHNOLOGY CO. LTD

HC-NP95A

China

85

Jiangsu Jiaao Medical Technology Co., Ltd.

JA95-1 Filtering half mask

China

86

Jiangsu Kangershun Protective Equipment Co., Ltd.

KES-002

China

87

Jiangsu Sanfo Outdoor Products Co., Ltd

CX9501-P

China

88

Jiangsu Yimao Filter Media Co., Ltd

9570K, 9560K

China

89

Jiaxing Yinuo Busway Co., Ltd.

YJ-P2

China

90

Jingzhou Strong Sciences & Technology Development Co.,ltd

ST-A9502, A9507

China

91

Jinhua Ai Kou Protective Equipment Co.,

AK003

China

92

Jinhua Jiadaifu Medical Supplies Co., Ltd.

Disposable Non-Medical Face Mask (KN95)

China

93

Jinwells (Tianjin) Science and Technology Co., Ltd.

JWS-1, JWS-2

China

94

Jinyi (Tianjin) Medical Technology Co., Ltd.

JY9501

China

95

Lanshan Shendun Technology Co., Ltd.

SD-KN95

China

96

Liaoning Dalian Jieying Energy Saving Environmental Protection Technology Development Co., Ltd.

JY-FH-F, JY-FH

China

97

Lu'an Bi Hai Protective Equipment Co., Ltd.

BH2020

China

98

Meizhuangchen Health Technology (Shenzhen) Co., Ltd.

ENKN95-001

China

99

Naton Medical Protective Mask (Zhuozhou) Co., Ltd

FS9501-L, FS9501-M, FS9501-S; FS9901-L, FS9901-M, FS9901-S

China

100

ORICH Medical Equipment (Tianjin) Co., Ltd.

N95 Folded Form (Non-sterile)

China

101

PURIFA Medical Production Co., Ltd.

BU-E978

China

102

Putian Sisen Technology Co.,Ltd.

AIBANA 001

China

103

Qingdao Bioforce-aid Technology Co., Ltd.

G9501

China

104

Qingdao Huaren Medical Product Co.,Ltd.

HRKFAM, HRKFBM

China

105

Qingdao Miuton Medical Co., Ltd

Stereoscopic type ear worn KN95 Protective Mask

China

106

Qingzhou Yaowang Pharmaceutical Co., Ltd

N95-FWJ

China

107

Quanding Medical Supplies Co., Ltd.

QD-FM004

China

108

Quanzhou Caier Paper Co., Ltd.

CC001

China

109

QUANZHOU LIGAO PROTECTIVE PRODUCT MANUFACTURER CO.,LTD

LG-DFM-01

China

110

Raxwell Industrial Technology (Shanghai) Co., Ltd

RX9501

China

111

Regina Miracle (Shenzhen) Ltd.

RM2020 MA-08

China

112

Rizhao Sanqi Medical & Health Articles Co., Ltd

RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505

China

113

Samding Craftwork Co., Ltd.

B13086

China

114

Shaanxi Hongji Pharmaceutical Co., Ltd.

HJF-E1

China

115

Shandong C.I.R.S. Garments Co., Ltd.

LSD008

China

116

Shandong Haidike Medical Products Co., Ltd​.

N95-V1

China

117

Shandong Yuerong Network Technology Co., Ltd

Auben-0598

China

118

Shanghai Dasheng Health Products Manufacture Company, Ltd.

DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1

China

119

Shanghai Earntz Nonwoven Co., Ltd.

EZKZ01C

China

120

Shanghai Gangkai Purifying Products Co. Ltd.

8022, 8012, 8013

China

121

Shanghai Homes Mask Co,ltd Company

HMS-801

China

122

Shanghai Tenry Pharmaceutical Co., Ltd.

TR-ZD01

China

123

Shanghai Yunqing Industrial Co., Ltd.

YQD95 KN95

China

124

Shangxian Minimal Invasive Inc.

​CD9501

China

125

Shenyang Shengshi Medical Technology Co., Ltd.

Folding type SHI002 (non-sterile)

China

126

Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd

FH

China

127

Shenzhen SanheXing Stickers Products Co., Ltd.

SHX01

China

128

Shenzhen Yunyifu Health Technology Co., LTD.

PM-P2

China

129

SPRO Medical Products (Xiamen) Co., Ltd.

D918, GL001, GL001A

China

130

Sure-On Industries Ltd

210-KN95

China

131

Suzhou Bolisi Medical Technology Co., Ltd

BS-9501L, BS-9501FL, BS-9502C, BS-9502FC

China

132

Suzhou Dongshan Precision Manufacturing Co., Ltd.​

DKW00

China

133

Suzhou Sanical Protective Product Manufacturing Co., Ltd

8015, 9015

China

134

Tengfei Tech. Co. Ltd.

TF-9006

China

135

Tianjin TEDA Filters Co., Ltd.

TEDA-P0652

China

136

Tongcheng Jiuxi Technology Co., Ltd.

JX-R950

China

137

UFI Filters (Shanghai) Co., Ltd.

35.005

China

138

UHEALTH MEDICAL (BEIJING) PROTECTIVE PRODUCTS CO., LTD.

117

China

139

Violet Home Textile Technology Co., Ltd.

ZLL377

China

140

Weini Technology Development Co., Ltd

FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951, FFP3 NR E-830V, FFP3 NR E-340V, FFP2 NR K-220

China

141

WENZHOU KADIBANG GARMENTS CO., LTD.

KBD-M01

China

142

Wilson Instruments (SHA) Co., LTD

WS-KZ-S4, WS-KZ-S4E

China

143

Winner Medical Co., Ltd

WN-N95FW, WN-N95FGIN

China

144

Wuhan Zonsen Medical Products Co., Ltd.

ZSFM-01, ZSFM-02

China

145

Xiamen Chengchuang Automotive Materials Co., Ltd.

XPM2121

China

146

XIAMEN LIANYI INDUDSTIRAL & TRADING CO., LTD.

LY9501

China

147

XIAMEN PROBTAIN NONWOVEN INC.

MP9011

China

148

Xuan Cheng Zooboo Sports Goods Co., Ltd.

ZB008

China

149

Yangzhou Medline Industry Co., Ltd.

I 9501, II 9501

China

150

Yicheng Dunhou Medical Health Co., Ltd

DHA01

China

151

Yiyang Taihe Technology Co. Ltd

YTH0001

China

152

YuTong Eco-Technology (SuQian) Co., Ltd

YT-07

China

153

Zhangzhou Easepal Industrial Co., Ltd.

D13003 and D13003AC

China

154

ZHEJIANG BOSIQI CASHMERE CO., LTD.

KANGJIAYI SS4020

China

155

Zhejiang Dongmeng Medical Equipment Co., LTD

EYTV139110051-02

China

156

Zhejiang Langqi Fashion Co., Ltd

XJB902

China

157

ZHEJIANG LILY UNDERWEAR CO., LTD

FM0402-966; FM0432-966; FM0201-966

China

158

ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO., LTD.

LY-N900-N909

China

159

ZHEJIANG MASHANG TECHNOLOGY CO., LTD

MSNF-01

China

160

ZHEJIANG SHUNFA SAFETY TECHNOLOGY CO., LTD

SF-K01, SF-K02

China

161

Zhejiang Yinda Biotechnology Co., Ltd.

YD-N2

China

162

Zhende Medical Co., Ltd.

N9501F

China

163

Zhengzhou Ruipu Medical Technology Co. Ltd

KN95

China

164

Zhongkang Protective Equipment Technology (Guangzhou) Co., Ltd

ZK601; ZK626

China

165

Zhuhai HealthPro Medical Equipment Co., Ltd

HB202001-WH, HN202001

China

166

ZIGONG WEIKANG MEDICAL EQUIPMENT CO., LTD

WJKZ-2

China

167

ZK-BEST (Xiamen) Environmental Science & Technology Co., Ltd.

ZKG9501, ZKG9501V

China

 

从附录A中删除呼吸器型号

(呼吸器型号不再授权)

 

SN

Date No longer Authorized

Manufacturer

Respirator Model(s) No Longer Authorized

Country of Manufacturer

1

10/15/2020

HeiQ Materials AG

HVB-FFP2-01

China

2

06/06/2020

Fujian Kang Chen Daily Necessities Co, Ltd.

K0450, 57793

China

3

05/07/2020

AAB (China) Co., Ltd

KN95

China

4

05/07/2020

Anshun Health and Medical Technology Co., LTD

AKF2002

China

5

05/07/2020

Bei (Dong Shan) Protective Supplies Co., LTD

B707

China

6

05/07/2020

Changsha JNEYL Medical Equipment Co., Ltd

JN-9501

China

7

05/07/2020

Changzhou Wedream Medical Device Co., Ltd

KN95

China

8

05/07/2020

Chongqing China Nano Technology Co., Ltd

ZN8005

China

9

05/07/2020

Chongqing Zaisheng Technology Co., Ltd.

ZS-A950

China

10

05/07/2020

Chuzhou Qiao Dong Industrial Co., Ltd

Langie KN95 FFP2

China

11

05/07/2020

Creative Concepts Manufacturing Ltd

02669, KN95

China

12

05/07/2020

CTT CO. Ltd.

KN95

China

13

05/07/2020

Daddybaby Co. Ltd.

KN95 FFP2

China

14

05/07/2020

DongGuan HuaGang Communication Technology Co., Ltd

KN95-A; KN95-B

China

15

05/07/2020

Dongguan Leihuo Medical Device Co., LTD

CPFM-100, CPFM-101, LH-KN95

China

16

05/07/2020

Dongguan Xianda Medical Equipment Co., Ltd

KN95

China

17

05/07/2020

Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd

KN95 Model 9051A

China

18

05/07/2020

Fujian Pageone Garment Co., Ltd

KN95

China

19

05/07/2020

Guangdong Fei Fan MStar Technology Ltd

KN95

China

20

05/07/2020

Guangdong Kaper Protection Technology Co., Ltd

KP-K02 (N95)

China

21

05/07/2020

Guangzhou Aiyinmei Co., LTD

A&F KN95

China

22

05/07/2020

Guangzhou Sunjoy Auto Supplies Co., LTD

Earhook folding type K1-K100, Headband folding type K1-K100

China

23

05/07/2020

Guangzhou Yihere Medical Technology Development Co., Ltd

YH-MFK-B95, YH-MFK-Z95

China

24

05/07/2020

Guizhou Bocai Medical Device Co., Ltd.

Bocai KN95

China

25

05/07/2020

Henan Fengzhihuang Industrial Co., Ltd

HF/KN95-3

China

26

05/07/2020

Henan Youmaisi Health Technology Co. LTD

YMS-AN95

China

27

05/07/2020

Huizhou Huinuo Technology Co., LTD

HV-N White 9501B

China

28

05/07/2020

Huizhou Jiahe Cubic Technology Co., LTD

KN95

China

29

05/07/2020

Huizhou Lexuslance Technology Co. Ltd.

LK 003

China

30

05/07/2020

Improve Medical (Hunan) Co., Ltd.

PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook

China

31

05/07/2020

Jiangsu Weichuangli New Materials Co., Ltd.

WCL-0075

China

32

05/07/2020

Jiangxi Hornet Industrial Co. Ltd.

S-KN95

China

33

05/07/2020

Jiangxi Yifengyuan Biological Engineering Co., Ltd.

N95, KN95

China

34

05/07/2020

Jinan Vhold Co., LTD

VH-95

China

35

05/07/2020

Juntech (Jiaxing) Healthcare Materials Co. Ltd

KN95

China

36

05/07/2020

Panzhihua Gangcheng Group Yasheng Industrial Co., Ltd.

KN95

China

37

05/07/2020

Qingdao Orphila Medical Technology Co. LTD.

OM-KN95-FFP2

China

38

05/07/2020

Qingyuan Leite Technology Development Co.

GV-0095A, GVHKN95

China

39

05/07/2020

Shandong Daddy's Choice Health Science and Technology Co., Ltd

Purism KN95

China

40

05/07/2020

Shandong Huishoutang Pharmaceutical Co

KN95

China

41

05/07/2020

Shandong Shengquan New Material Co., Ltd

SNN70370B (Willow leaf form valveless)

China

42

05/07/2020

Shauguan Taijie Protection Technology Co. Ltd.

KN95

China

43

05/07/2020

Shenzhen Horb Technology Corp., Ltd

1.7.02.02.0001

China

44

05/07/2020

Shenzhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies

2626-1 KN95

China

45

05/07/2020

Sunright Medical Technology (GuangDong) Co., LTD

KN95-C3

China

46

05/07/2020

Tianjin Benmo Medical Equipment Co., Ltd.

KN95

China

47

05/07/2020

Winner Medical Co. Ltd.

WN-N95FG

China

48

05/07/2020

Yiwu Henghao household products Co., Ltd

HH-KN95-001

China

49

05/07/2020

Yiwu Yifan Knitting Co. Ltd

KN95

China

50

05/07/2020

Zhangzhou Easepal Industrial Corp.

MASK-104

China

51

05/07/2020

Zhejiang Baiyi Intelligent Garment Co LTD

KN95

China

52

05/07/2020

Zhejiang Shengtai Baby Products Co Ltd

KN95

China

53

05/07/2020

Zhengzhou QBS New Material Co., LTD

KN95

China

54

05/07/2020

Zhengzhou Wanshenshan Healthcare PPE Co., Ltd.

KN95

China

 

 

 

 

 

FI003 FDA针对一次性面罩再次发布EUA,将不再新增EUA厂家!--Update

发布时间:2021-03-25
作者: 王小康  
成文日期: 2021年3月25日