Wen Xu

FDA Filings

This page includes the latest FDA filings for Wen Xu. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008570547
FEI Number3008570547
NameWen Xu
Owner & OperatorBeijing Rongrui Century Science Technology Co.,Ltd
Contact Address3 Floor, West Zone, No. 1 Building, No.7 Fengxian Middle Rd. Haidian District
Beijing CN-11 Beijing 100094 CN
Official Correspondent
  • Ting Chen
  • 086-010-51658220-135
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Importing Logistics Registration
ImporterCommonSpirit Health
Address444 W.Lake Street, STE. 2500
Chicago, IL 60606 UNITED STATES
Phone1 312 7417000
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way
Ellicott, MD 21042 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3016589969
FEI Number3016589969
NameWen Xu
Owner & OperatorChongqing Bio NewVision Medical Equipment Ltd.
Contact AddressFulicheng Zhihuiguoji Building 9F, Jingh
Chongqing CN-50 Chongqing 401331 CN
Official Correspondent
  • Ray Wang
  • 86-10-56335780-x
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way Ellicott City MD
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

Registration Number3015337425
FEI Number3015337425
NameWen Xu
Owner & OperatorZhejiang TuoZhen Medical Technology Co.,Ltd.
Contact AddressNo.5,Hanxiao Road,Fotang Town
YiWu CN-33 Zhejiang 322000 CN
Official Correspondent
  • XiaoYing Ye
  • 86-010-56335780-x
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

Registration Number0
FEI Number0
NameWen Xu
Owner & OperatorQiqihar Hengxin Medical Supplies, Ltd
Contact AddressWantun, Tiefeng District, Qiqihar
Qiqihar CN-23 Heilongjiang 161000 CN
Official Correspondent
  • Ray Wang
  • 86-045-5656995-x
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way Ellicott City MD
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

Registration Number3006621103
FEI Number3006621103
NameWen Xu
Owner & OperatorANREI MEDICAL (HZ) CO., LTD.
Contact AddressNO. 3, AVE. 8, HEDA HANGZHOU CHINA
HANGZHOU CN-33 Zhejiang 310018 CN
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Importing Logistics Registration
ImporterNorgenix
Address101 W. Saint John St., Suite 307
Spartanburg, SC 29306 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way Ellicott City MD
Ellicott, MD 21042 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198

Registration Number3012034017
FEI Number3012034017
NameWen Xu
Owner & OperatorHeaven Healthcare Co., Ltd.
Contact AddressRoom 1905,Xingyuan Int'l Bldg, Yuecheng District,Shaoxing,China
Shaoxing CN-33 Zhejiang 312000 CN
Official Correspondent
  • Jun Yu
  • 086-575-85154179-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

Registration Number3014498854
FEI Number3014498854
NameWen Xu
Owner & OperatorHebei Baiyang Bed Industry Manufactory
Contact AddressNo.22 kangming South Road Xushui County
BaoDing CN-13 Hebei 072550 CN
Official Correspondent
  • ray wang
  • 86-313-8601388-x
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way Ellicott City MD
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

Registration Number3016688836
FEI Number3016688836
NameWen Xu
Owner & OperatorCanyon Medical Inc.
Contact AddressBuilding 3, Phase 2 Accelerator, No. 11 People's Republic of China
Nanjing CN-32 Jiangsu 210032 CN
Official Correspondent
  • Huiqi Jiang
  • 86-025-85421825-x
US Agent
  • Wen Xu
  • 443 8968583
  • ray.wang@believe-med.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way Ellicott City MD
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

Registration Number3013546336
FEI Number3013546336
NameWen Xu
Owner & OperatorShanghai Audental Bio-Material Co., Ltd.
Contact Address1602, 88 Sibao Road, Sijing Zhen Songjiang District
Shanghai CN-31 Shanghai 201601 CN
US Agent
  • Wen Xu
  • 884 8968583
  • ray.wang@believe-med.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4611 Maydew Mews Way Ellicott City MD
Ellicott, MD 21042 US
Establishment TypeManufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Wen Xu [Heaven Healthcare Co., Ltd.]
Isolation gown2020-04-17
Wen Xu [Heaven Healthcare Co., Ltd.]
Surgical Mask2020-04-14
Wen Xu [Heaven Healthcare Co., Ltd.]
Face Mask2020-04-14
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
Disposable face mask2020-04-02
Wen Xu [Qiqihar Hengxin Medical Supplies, Ltd]
Disposable medical mask2020-03-29
Wen Xu [Canyon Medical Inc.]
Disposable Face Masks (Model: NKY-KZ-170X95, NKY-KZ-175X95)2020-03-25
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Anrei Health Care Particulate Respirator and Surgical Mask2020-03-22
Wen Xu [Qiqihar Hengxin Medical Supplies, Ltd]
Non-Surgical Isolation Gown2020-03-17
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
Medical Face Shield RMZ-0022020-03-16
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
Medical Face Shield RMZ-0012020-03-16
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
Medical Goggles RYZ-0012020-03-16
Wen Xu [Chongqing Bio NewVision Medical Equipment Ltd.]
Ophthalmic Camera2020-02-11
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Single use stone retrieval basket2019-12-23
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
retrieval net2019-12-23
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Sclerotherapy Needle2019-11-07
Wen Xu [Heaven Healthcare Co., Ltd.]
Cleansing Wipes2019-10-23
Wen Xu [Heaven Healthcare Co., Ltd.]
Ice Pack2019-10-23
Wen Xu [Heaven Healthcare Co., Ltd.]
Hot Cold Pack2019-10-23
Wen Xu [Heaven Healthcare Co., Ltd.]
Splinter Probes2019-10-23
Wen Xu [Zhejiang TuoZhen Medical Technology Co.,Ltd.]
Medical Compression Stockings2019-04-03
Wen Xu [Zhejiang TuoZhen Medical Technology Co.,Ltd.]
Medical Compression Hosiery2019-04-03
Wen Xu [Zhejiang TuoZhen Medical Technology Co.,Ltd.]
Elastic Stocking2019-04-03
Wen Xu [Heaven Healthcare Co., Ltd.]
First Aid Kit, CPR Mask Keychain2018-12-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Emergency blanket2018-12-20
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Single Use Grasping Forceps2018-07-17
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Polyp Collection Kit2018-07-17
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Single Use Grasping Forceps2018-07-17
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Polypectomy Snare2018-07-17
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Table2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Manual Operation Table2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Chair2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Cabinet2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Electric Delivery Table2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Manual Operation Table2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
wheeled Stretcher2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Mattress2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Electric Hospital Bed2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Manual Bed2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Common Nursing Bed2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Common Delivery Bed2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Child Bed2018-04-25
Wen Xu [Hebei Baiyang Bed Industry Manufactory]
Medical trolley2018-04-25
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Single-use Guide Wire2018-02-06
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Single-use Cleaning Brushes2018-02-06
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Single-use Bite Block2018-02-06
Wen Xu [Heaven Healthcare Co., Ltd.]
Tourniquet2017-12-14
Wen Xu [Heaven Healthcare Co., Ltd.]
Non-woven Cap2017-12-14
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental A63;Audental A60;Audental A58;Audental A50;Audental A46;Audental A41;Audental A68;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental A60+;Audental A56;Audental A50+;Audental A52+;Audental A50B;Audental A50C;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental A42;Audental U75;Audental U73;Audental U55;Audental U602017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental 98;Audental 89;Audental 86+; Audental 87;Audental 86A;Audental 84;Audental 76;Audental 75;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental 90;Audental 86;Audental 74 ;Audental 50; Audental 03; Audental 04;Audental 22; Audental 40;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental 75+;Audental 65;Audental 62;Audental 54;Audental 52;Audental 52+;Audental 45;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental 40A;Audental A52;Audental A6;Audental A62;Audental A83;Audental A77;Audental A75;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental Pd70;Audental Pd71;Audental Pd61;Audental Pd58;Audental Pd55;Audental Pd50;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental Pd49;Audental A10;Audental A20;Audental A35;Audental A25;Audental A25+;Audental U40;Audental 43+;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental Pal;Audental Pal 2;Audental 60;Audental Pd80;Audental Pd80+;Audental Pd76;Audental Pd75;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental 15; Audental 40+; Audental 30;Audental 35; Audental 43;Audental 02;Audental 54;Audental 61;2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental Ultra; Audental Ultra H; Audental Excel; Audental Excel+; Audental Plus2017-05-05
Wen Xu [Shanghai Audental Bio-Material Co., Ltd.]
Audental Pt15;Audental 43-;Audental Bond;Audental Pd25;Audental Cobalt; Audental Cobalt H;2017-05-05
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
Disposable Temporary Pacing Cable2016-10-26
Wen Xu [Heaven Healthcare Co., Ltd.]
Non-adherent Dressing,Adhesive Dressing Plaster2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Wound Dressing,Alginate Dressing2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Hydrocolloid Pimple Patch2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Hydrocolloid Dressing2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Acne Patch2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
dry prep sponge stick2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Medical Gauze Sponge2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Burn Dressing2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Silicone Gel Scar Dressing2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Non-woven Swabs2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Medical Tape,Wound Closure Strip2016-01-20
Wen Xu [Heaven Healthcare Co., Ltd.]
Medical Bandage2016-01-20
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
SonoSure? SonoHysterography and Endometrial Sampling Device2014-03-23
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
SonoSure? SonoHysterography and Endometrial Sampling Device2014-03-23
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
Rescue Single Use Grasping Forceps2013-01-17
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSY017DN2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RST017DI2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RST017DA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RST004CA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RST001DI2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RST001DA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ017DI2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ017DA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ006CA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ003DA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ002DA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ001DA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Sensor RSJ001CA2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
SpO2 Probe2011-07-25
Wen Xu [Beijing Rongrui Century Science Technology Co.,Ltd]
CABLE, ELECTRODE2010-09-13
Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]
SINGLE-USE BIOPSY FORCEPS2007-08-29

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Import IDShipmentCargo DescriptionQuantity
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2020042469567Yantian,China (Mainland) -> Oakland, CaliforniaSAFETY MASK1 PCS
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