1C1N336313-5-GB1
Ref 1C1N336313-5-GB1Model Aura Plus
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number502431017F 05024310993703 | Date7 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Ireland
Specification
- Model / Reference
- Aura Plus, 1C1N336313-5-GB1
- Primary DI / UDI-DI
- 05024310993703
- Basic UDI-DI
- 502431017F
- EMDN Code
- A100199 Devices for abdominal ostomy - one piece - other
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000033194
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Welland Medical Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No