andorate® Irrigation Tubing
by GA Health Company Limited 2 variants
Ref GAR083WOC
Active
CE MDR
Valid until
9 Nov 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberHK23/00000192 | Date7 May 2025 | StatusActive |
Certificates
- HK23/00000192 Active
Quality assurance EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 7 May 2025
- Expires
- 9 Nov 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Irrigation Tubing
- Model / Reference
- GAR083WOC
- Primary DI / UDI-DI
- 04897106957323
- Basic UDI-DI
- 489710695GAR073FV
- EMDN Code
- G030899 Instruments for gastro-intestinal endoscopy and eco-endoscopy, single-use - other
- Device Class
- Class IIa
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- HK-MF-000019784
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Ga Health Company Limited
Properties
Other properties (12)
- 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