GA HEALTH COMPANY LIMITED

FDA Device Registration & Listing · Hong Kong, HK · Registration 3014749926

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014749926
FEI Number
3014749926
Entity Name
GA HEALTH COMPANY LIMITED
City/State/Country
Hong Kong, HK
Establishment Address
Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza, 138 Shatin Rural Committee Road, Shatin, N.T., Hong Kong None, HK
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
GA Health Company Limited (Owner Number: 10061258)
Owner / Operator Contact Address
Unit 1511-13 & 15, 15/F, Tower 2, Grand Central Plaza,, 138 Shatin Rural Committee Road, Shatin, N.T., Hong Kong, HK-NOTA None, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

andorate ENDO082US ENDO040US aquapulse ENDO126US ENDO092US andorate andorate ENDO130US ENDO230US andorate ENDO160CO2LBUS ENDO160CO2SBUS ENDO145CO2LBUS ENDO145CO2SAUS andorate ENDO242US ENDO018SUS ENDO037US ENDO081US andorate andorate ENDO028SUS ENDO046US Andorate ENDO241US ENDO004US Andorate ENDO092US ENDO015SUS ENDO087US ENDO092US ENDO087US andorate Andorate

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CBC Bottle, Collection And Trap, Breathing System (Uncalibrated) General Hospital Class 2 880.6740 2020-04-16
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-05-18
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2019-12-04
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-02-07
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-10-08
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-10-08
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-10-08
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-10-08
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-10-08
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-10-08
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2020-05-21
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2023-07-10
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-07-10
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2023-07-10
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2020-06-26
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2020-06-26
OCU Endoscopic Storage Cover Gastroenterology, Urology Class 2 876.1500 2021-05-26
HMP Pad, Eye General, Plastic Surgery Class 1 878.4440 2020-05-21

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 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014749926. Last updated year: 2026. Please use registration number 3014749926 when referencing this establishment in official correspondence.
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