Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044707938

FEI Number

3044707938

Entity Name

GA HEALTH VIETNAM COMPANY LIMITED

City/State/Country

Ho Chi Minh Tay Ninh, VN

Establishment Address

Factory D1-1, VL3 Road, Vinh Loc 2 Industrial Park, My Yen Commune, Tay Ninh, Ho Chi Minh Tay Ninh 1102129614, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GA Health Vietnam Company Limited (Owner Number: 10095510)

Owner / Operator Contact Address

Factory D1-1, VL3 Road, Vinh Loc 2 Industrial Park, My Yen Commune, Tay Ninh, Ho Chi Minh, VN-37 1102129614, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Andorate Andorate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2026-03-23
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2026-03-23
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2026-03-23
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2026-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GA Health Vietnam Company Limited

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-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

Registration Number	Establishment Name	Location
3013348547	CIPHER SURGICAL LTD	Coventry, GB
2528981	LYNX Medical Pennsylvania	ERIE, PA, US
3010383847	STERISERVICES	Bernay Eure, FR
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US
3010707607	KARL STORZ SE & CO. KG	NEUHAUSEN OBECK Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044707938. Last updated year: 2026. Please use registration number 3044707938 when referencing this establishment in official correspondence.