TRANSKIN WaterProof & Transparent Film Dressing Roll
Ref TS-RD102M, TS-RD1010MModel TS-RD1010M、TS-RD102M
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 | Number489711514TranSkinVE | Date9 Apr 2025 | 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- Withdrawn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
- TRANSKIN WaterProof & Transparent Film Dressing Roll
- Model / Reference
- TS-RD1010M、TS-RD102M, TS-RD102M, TS-RD1010M
- Primary DI / UDI-DI
- 04897115147890, 04897115147906
- Basic UDI-DI
- 489711514TranSkinVE
- EMDN Code
- M04010299 Fixing dressings - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- HK-MF-000042511
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Savewo Limited
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