Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009064553

FEI Number

3009064553

Entity Name

SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN, SHANGHAI 200041, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD. (Owner Number: 10056224)

Owner / Operator Contact Address

25D, HEYI BUSINESS PLAZA, NO. 420 JIANGNING RD.,JINGAN, SHANGHAI, CN-SH 200041, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Injection Needle Disposable Bite Blocks Disposable Cleaning Brushes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-11-16
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2017-11-16
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

SHANGHAI HEYI MEDICAL INSTRUMENTS CO., LTD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

Similar Registrations

Registration Number	Establishment Name	Location
3008040402	Olympus Vietnam Co. Ltd.	Dong Nai City, VN
1647149	Steritec Services, LLC	ATHENS, TX, US
1056129	ENDO-THERAPEUTICS, INC.	CLEARWATER, FL, US
3013526170	Jiangsu Vedkang Medical Science and Technology Co.,Ltd.	Changzhou Jiangsu, CN
3003790304	GYRUS ACMI, INC.	Westborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009064553. Last updated year: 2026. Please use registration number 3009064553 when referencing this establishment in official correspondence.