Chest Drainage Catheter
by Romsons Group Private Limited 4 variants
Ref GS-5010
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8902120G003SN | Date4 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Thoracic Drainage Catheter
- Model / Reference
- GS-5010
- Primary DI / UDI-DI
- 08902120501059, 08902120501073, 08902120501042, 08902120501035, 08902120501080, 08902120501066, 08902120501097, 08902120501028
- Basic UDI-DI
- 8902120G003SN
- EMDN Code
- A0601010401 Thoracic drainages (straight and angled)
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IN-MF-000024594
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Romsons Group Private 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