Identity
- Trade Name
- Suction Valve EUDAMEDAndorate® Suction Valve FDA UDI
- Generic Name
- Endoscope suction valve, single-use FDA UDI
- Device Name
- Suction Valve EUDAMED
- Model / Reference
- GAR109A EUDAMEDFDA UDIGAR037A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106958399 EUDAMED04897106950331 EUDAMEDFDA UDI04897106954629 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695GAR004AKU EUDAMED489710695GAR109ALJ EUDAMED
- FDA Product Code
- ODC FDA UDIKTI FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscope suction valve, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI874.4680 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Suction Valve by Ga Health Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489710695GAR004AKU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GA Health Company Limited
- EUDAMED SRN
- HK-MF-000019784
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 338a4867-f703-49e8-8c80-3e6460e2d7a8 61 fields · synced Jul 12, 2026
- FDA UDI e456a914-b8c9-4bed-8dd7-f8b5b25ffcd4 32 fields · synced May 29, 2026
- FDA UDI c2160d21-cdff-44ca-8543-e9eab147acf7 32 fields · synced May 30, 2026
- EUDAMED f9f99e64-7782-4ab9-abba-c16b03b6474a 61 fields · synced Jul 10, 2026
- EUDAMED 862530d9-7224-4cb6-b799-8accdfbf3f31 61 fields · synced Jul 12, 2026