Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006621103

FEI Number

3006621103

Entity Name

Anrei Medical (HZ) CO., LTD.

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

NO. 3 AVE. 8, HEDA HANGZHOU, CHINA, HANGZHOU Zhejiang 310018, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANREI MEDICAL (HZ) CO., LTD. (Owner Number: 9106461)

Owner / Operator Contact Address

NO. 3, AVE. 8, HEDA HANGZHOU, CHINA, HANGZHOU, CN-ZJ 310018, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201771

PMA Number

N/A

All Registered Proprietary Names

Single-use Bite Block VersaGraspTM Single-Use Grasping Forceps Single-Use Grasping Forceps single use stone retrieval basket/single use retrieval basket Endoscopic Grasping Forceps Pulmonary Grasping Forceps Single Use Injection Needle RatTooth Grasping Forceps RatTooth/Alligator Grasping Forceps Alligator Grasping Forceps, Long Alligator Grasping Forceps RatTooth Grasping Forceps-Pediatric Single-use Guide Wire Single-use Cold Snare/Cold Snare SINGLE-USE BIOPSY FORCEPS Single Use Rotatable and Repositionable Hemoclip/Hemostatic Clip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2018-02-06
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2018-07-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-04-29
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-05-31
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2013-01-17
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-02-06
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-07-12
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2007-08-29
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2020-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

ANREI MEDICAL (HZ) CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K923489	Cox Medical Ent., Inc.	COX DISPOSABLE RETRIEVAL DEVICES	1992-09-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718

Similar Registrations

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3014926389	Jiangsu JianYu Health Medical Co., Ltd	Changzhou City Jiangsu, CN
3004930567	SUZHOU SUNING UNDERPAD CO., LTD.	SUZHOU, JIANGSU PROVINCE, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006621103. Last updated year: 2026. Please use registration number 3006621103 when referencing this establishment in official correspondence.