Elastus Sigmafilm
by Reskin Medical NV EUDAMED
Active
Ref 72642, 72643
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5430002895SIGMAFILMAD | Date5 Mar 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Sigma Film
- Model / Reference
- 72642, 72643
- Primary DI / UDI-DI
- 05430002895758, 05430002895765
- Basic UDI-DI
- 5430002895SIGMAFILMAD
- Direct Marketing DI
- 0543000289575805430002895765
- EMDN Code
- M04040601 Polyurethane dressings, non-combined
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- BE-MF-000012226
Other devices from Reskin Medical NV
Properties
Other properties (12)
- 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