Canwell
by Canwell Medical Co., Ltd. 1,000+ variants
Ref 121241104
Active
CE MDR
Valid until
1 Mar 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6142788CE02 | Date26 May 2026 | StatusActive |
Certificates
- 6142788CE02 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 26 May 2026
- Expires
- 1 Mar 2029
- Reason
- Ar data change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Metal Bone Plate
- Model / Reference
- 121241104
- Primary DI / UDI-DI
- 06941755125164
- Basic UDI-DI
- 69429802KH0001GB
- EMDN Code
- P09120501 Osteosynthesis compression plates
- Device Class
- Class IIb
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000025329
- Authorised representative
- Llins Service & Consulting GmbH DE-AR-000009077
Other devices from Canwell Medical Co., Ltd
Properties
Other properties (12)
- Sterile: 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