Conwell
by Conwell Medical Co., Ltd. 448 variants
Ref 5103 Plastic Adjustable Collar (S)Model 5101, 5102, 5103, 5104, 5106, 5107, 5108, 5109, 51100
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 | Number471987893COLLAR-51000Y5 04719878931335 | Date26 Mar 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- Withdrawn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
Specification
- Device Name
- Soft Support, Brace, Orthosis (Collar series)
- Model / Reference
- 5101, 5102, 5103, 5104, 5106, 5107, 5108, 5109, 51100, 5103 Plastic Adjustable Collar (S)
- Primary DI / UDI-DI
- 04719878931335
- Basic UDI-DI
- 471987893COLLAR-51000Y5
- EMDN Code
- Y060312 Cervical spine orthoses
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- TW-MF-000012101
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Conwell Medical Co., Ltd.
Properties
Other properties (13)
- Sterile: 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