3-piece valve kit (Suction +2 more)

FDA UDIEUDAMED

Class II (US FDA UDI)

by GA Health Company Limited

Identity

Trade Name: 3-piece valve kit (Suction, Air/Water and Biopsy Valves) FDA UDI
Generic Name: Endoscope channel support kit FDA UDI
Model / Reference: EN10229 FDA UDI

Identifiers

Primary DI / UDI-DI: 04897106951093 FDA UDI
FDA Product Code: ODC FDA UDI
OCX FDA UDI
GMDN Term: Endoscope channel support kit FDA UDI
Models / Variants: Suction FDA UDIEUDAMED
Air FDA UDIEUDAMED
Water and Biopsy Valves FDA UDIEUDAMED

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscope channel support kit

3-piece valve kit (Suction +2 more) by GA Health Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 3 models

Similar devices

Also classified as Endoscope channel support kit.

Check-Flo — COOK INCORPORATED · Class II
4-Piece Valve Kit — Micro-tech Usa · Class II
CeroFrict — SML Med-Tech Solutions Limited · Class II
CeroFrict — SML Med-Tech Solutions Limited · Class II
5-Piece Valve Kit — Micro-tech Usa · Class II
Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
CeroFrict — SML Med-Tech Solutions Limited · Class II
CeroFrict — SML Med-Tech Solutions Limited · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: GA Health Company Limited

Sources (2)

FDA UDI bfae628d-302a-45c6-9c26-c8c24ddad421 32 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 1, 2026