Anrei Medical Hz Co L T D

FDA Filings

This page includes the latest FDA filings for Anrei Medical Hz Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006621103
• FEI Number: 3006621103
• Name: Wen Xu
• Owner & Operator: ANREI MEDICAL (HZ) CO., LTD.
• Contact Address: NO. 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:
  • Importer: Norgenix
  • Address: 101 W. Saint John St., Suite 307 ; Spartanburg, SC 29306 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4611 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

FDA Filings

Device Company	Device	Date
GUDID 16948318996794 Anrei Medical(HZ) Co.,Ltd.	VersaGrasp Single use Grasping Forceps M0067802000	2023-11-24
GUDID 06948318996094 Anrei Medical(HZ) Co.,Ltd.	VersaGrasp Single use Grasping Forceps M0067802000	2023-11-09
GUDID 06948318946785 Anrei Medical(HZ) Co.,Ltd.	Medtronic	2022-04-14
GUDID 06948318946778 Anrei Medical(HZ) Co.,Ltd.	Medtronic	2022-04-14
GUDID 26948318968828 Anrei Medical(HZ) Co.,Ltd.	Anrei	2021-05-24
GUDID 16948318903921 Anrei Medical(HZ) Co.,Ltd.	Anrei	2021-05-24
GUDID 06948318912346 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912339 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912322 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912315 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912308 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912292 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912285 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
GUDID 06948318912278 Anrei Medical(HZ) Co.,Ltd.	Anrei	2020-11-09
MSH Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Anrei Health Care Particulate Respirator and Surgical Mask	2020-03-22
LQC Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Single use stone retrieval basket	2019-12-23
FFL Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	retrieval net	2019-12-23
GCB Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Sclerotherapy Needle	2019-11-07
GUDID 16948318968807 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-10-28
GUDID 16948318903983 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-10-28
GUDID 16948318903938 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-10-28
GUDID 16948318903907 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-10-28
GUDID 16948318903822 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-10-28
GUDID 26948318968644 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-03-25
GUDID 26948318968637 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-03-25
GUDID 26948318968620 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-03-25
GUDID 26948318968613 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-03-25
GUDID 26948318968606 Anrei Medical(HZ) Co.,Ltd.	Rescue	2019-03-25
PTS Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Single Use Grasping Forceps	2018-07-17
KDQ Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Polyp Collection Kit	2018-07-17
GDJ Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Single Use Grasping Forceps	2018-07-17
FGX Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Polypectomy Snare	2018-07-17
OCY Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Single-use Guide Wire	2018-02-06
MNL Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Single-use Cleaning Brushes	2018-02-06
MNK Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Single-use Bite Block	2018-02-06
PMN K133144 | PGK Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	SonoSure? SonoHysterography and Endometrial Sampling Device	2014-03-23
PMN K133144 | HFE Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	SonoSure? SonoHysterography and Endometrial Sampling Device	2014-03-23
PMN K101298 | OCZ Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	Rescue Single Use Grasping Forceps	2013-01-17
FCL Wen Xu [ANREI MEDICAL (HZ) CO., LTD.]	SINGLE-USE BIOPSY FORCEPS	2007-08-29