Conwell
by Conwell Medical Co., Ltd. 448 variants
Ref 5502 Soft Back Support 8" (XXL)Model 5501, 5502, 5503, 5504, 5505, 5506, 5507, 5508, 5509, 5512, 5513, 5514, 5515, 5518, 5519, 55200, 5524, 5525, 71010, 71020
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 | Number471987893BACK-55000HZ 04719878932998 | 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- Withdrawn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 (Back series)
- Model / Reference
- 5501, 5502, 5503, 5504, 5505, 5506, 5507, 5508, 5509, 5512, 5513, 5514, 5515, 5518, 5519, 55200, 5524, 5525, 71010, 71020, 5502 Soft Back Support 8" (XXL)
- Primary DI / UDI-DI
- 04719878932998
- Basic UDI-DI
- 471987893BACK-55000HZ
- EMDN Code
- Y060306, Y060308, Y060399, Y060403, Y060406, Y061215
- 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 (12)
- Sterile: No
- Implantable: No
- Reusable: 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