Mepitel One
by Mölnlycke Health Care AB 11 variants
Ref 289000
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number733243000000000022JJ 07332551023713 | Date16 Sep 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 289000
- Primary DI / UDI-DI
- 07332551023713
- Basic UDI-DI
- 733243000000000022JJ
- EMDN Code
- M04040701 Silicone dressings, non-combined
- Device Class
- Class IIb
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000014042
Other devices from Mölnlycke Health Care AB
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