Identity
- Trade Name
- Bronchoscope Biopsy Valve EUDAMEDandorate® Biopsy Valve FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- Biopsy Valve EUDAMED
- Model / Reference
- GAR021 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106955169 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695GAR028-SS5 EUDAMED
- FDA Product Code
- KTI FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Tissue morcellation system handpiece, line-powered
Bronchoscope Biopsy Valve by Ga Health Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489710695GAR028-SS5 | 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 (2)
- EUDAMED 07ccb243-bca7-485f-a97d-29cca18764d0 61 fields · synced Jul 17, 2026
- FDA UDI 1ff575a9-1d8b-4848-bd39-87314cf47907 32 fields · synced May 30, 2026