Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008567544

FEI Number

3008567544

Entity Name

GREAT GROUP MEDICAL CO LTD.

City/State/Country

Changhua County, TW

Establishment Address

No.168, Xingong 2nd Rd., Tianzhong Township, Changhua County 52046, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Great Group Medical Co Ltd. (Owner Number: 10045498)

Owner / Operator Contact Address

No.168, Xingong 2nd Rd., Tianzhong Township, Changhua County, TW-CHA 52046, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nonrebreathing mask GGM Disposable Heater Wire Breathing Circuit Respiratory Humidifier, Models VH-2100, VH2600A, and VH-2600 Ventilator tubing Respiratory gas humidifier GGM Breathing Circuit Bacterial Filter Therapeutic humidifier for home use Nasal oxygen cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2013-11-24
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2021-04-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-08-19
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2013-11-24
OGG	Humidifier Nebulizer Kit	Anesthesiology	Class 2	868.5450	2013-11-24
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2021-03-04
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2013-11-24
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2013-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Great Group Medical 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
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

Similar Registrations

Registration Number	Establishment Name	Location
3017923969	ANIBA HEALTH SOLUTIONS LLC.	Great Neck, NY, US
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
9710391	POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.	XIAMEN Fujian, CN
9611500	Draegerwerk AG & Co. KGaA	LUEBECK Schleswig-Holstein, DE
3005460813	TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD	Taizhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008567544. Last updated year: 2026. Please use registration number 3008567544 when referencing this establishment in official correspondence.