CO2 Extend Tubing with Luer Connector
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- CO2 Extend Tubing with Luer Connector EUDAMEDandorate® CO2 Extend Tubing with Luer Connector FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- CO2 Source Tubing with Luer Connector EUDAMED
- Model / Reference
- GAR091 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04897106953790 EUDAMEDFDA UDI
- Basic UDI-DI
- 489710695GAR047FU EUDAMED
- 510(k) Number
- K200388 FDA UDI
- FDA Product Code
- FCX FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Endoscopic insufflation tubing set, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
No
Single Use
No
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
CO2 Extend Tubing with Luer Connector by Ga Health Company Limited — Class IIa — 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 | 489710695GAR047FU | 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 (2)
- EUDAMED b3c7118f-4585-498d-89b7-77f4a8b8a81d 61 fields · synced Jul 20, 2026
- FDA UDI c030db06-9755-4dc2-917f-f6079d43a4fd 33 fields · synced May 30, 2026