Air Water Channel Cleaning Adapter + 4-piece Valve Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Air Water Channel Cleaning Adapter + 4-piece Valve Kit EUDAMEDandorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Air Water Channel Cleaning Adapter + 4-piece Valve Kit EUDAMED
- Model / Reference
- GAR105092 EUDAMEDFDA UDIGAR3846 EUDAMED101094 EUDAMED101068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106955831 EUDAMEDFDA UDI04897106957682 EUDAMED04897106958641 EUDAMED04897106958603 EUDAMED04897106957729 EUDAMED
- Basic UDI-DI
- 489710695GAR3846M5 EUDAMED
- FDA Product Code
- FFY FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscope channel support kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.1500 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
Air Water Channel Cleaning Adapter + 4-piece Valve Kit by Ga Health Company Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 489710695GAR3846M5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (8)
- EUDAMED 704a4ee7-9a33-44f8-84ef-6ad2b7bba0f2 61 fields · synced Oct 6, 2026
- EUDAMED 2cbce366-e6b8-4bd3-b441-f90e88b74dd4 61 fields · synced May 17, 2026
- EUDAMED dfda2b9a-4ca6-4fb9-b901-f42408685620 61 fields · synced May 17, 2026
- EUDAMED 1525ef84-c06a-4308-bddd-28a0eb35fdca 61 fields · synced May 17, 2026
- EUDAMED e6fbdba4-3129-4cd1-96e3-c368a1b57ad0 61 fields · synced May 18, 2026
- FDA UDI 27cdc3eb-5543-4622-912f-101c6c08de9c 32 fields · synced May 30, 2026
- EUDAMED 8fa6a7df-574b-41c5-8d2e-3726830ef114 61 fields · synced Jul 8, 2026
- EUDAMED 87595eeb-7930-4ebe-9aa9-22699687c76b 61 fields · synced Jul 15, 2026