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Air Water Channel Cleaning Adapter + 3-piece Valve Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 101067Ref GAR3865Ref 101047Ref GAR3804Ref GAR105087
Identity
- Trade Name
- Air Water Channel Cleaning Adapter + 3-piece Valve Kit EUDAMEDandorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- Air Water Channel Cleaning Adapter + 3-piece Valve Kit EUDAMED
- Model / Reference
- 101067 EUDAMEDGAR3865 EUDAMEDFDA UDI101047 EUDAMEDGAR3804 EUDAMEDGAR105087 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106958597 EUDAMED04897106955817 EUDAMEDFDA UDI04897106958566 EUDAMED04897106957651 EUDAMED04897106957699 EUDAMED04897106957712 EUDAMED04897106959259 EUDAMED
- Basic UDI-DI
- 489710695GAR3804LM EUDAMED489710695101047SQ EUDAMED
- FDA Product Code
- OCX FDA UDIODC 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 I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Category: Tissue morcellation system handpiece, line-powered
Air Water Channel Cleaning Adapter + 3-piece Valve Kit by Ga Health Company Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Tissue morcellation system handpiece, line-powered.
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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 | 489710695GAR3804LM | 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 (10)
- EUDAMED 1844934d-5d39-4fb8-b428-c368b6f41a77 61 fields · synced Aug 1, 2026
- EUDAMED 91456bcb-0634-47d7-8b72-0fa968adf027 61 fields · synced May 16, 2026
- EUDAMED ff952041-e3dc-4f99-b72a-f55cb7ed2ea6 61 fields · synced May 17, 2026
- EUDAMED 6db8b98d-c199-4396-9671-7dadea0a3090 61 fields · synced May 17, 2026
- EUDAMED 5f2c78c4-1115-40c8-9041-f05c2db590ab 61 fields · synced May 17, 2026
- EUDAMED 11d3b879-767d-4dda-8b34-39d4c68a238e 61 fields · synced May 19, 2026
- FDA UDI 5678227b-2092-4dce-948e-fb40e7cebebe 32 fields · synced May 30, 2026
- EUDAMED 945b9812-b264-4e80-9ef7-669b2f1c2cee 61 fields · synced Jul 14, 2026
- EUDAMED bafff5a1-207b-458f-bb8a-34f05e37f31d 61 fields · synced Jul 25, 2026
- EUDAMED a0666941-1527-4bbb-b17f-3957a3c2ef97 61 fields · synced Aug 1, 2026