Rolle
by Andanza GmbH EUDAMED
Active
Ref K1010RO
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4260322K1010ROU7 | Date24 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Rolle
- Model / Reference
- K1010RO
- Primary DI / UDI-DI
- 04260322419133
- Basic UDI-DI
- 4260322K1010ROU7
- EMDN Code
- M9099 General and specialist medical devices – other (suture patches see h900102)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000049142
Other devices from Andanza GmbH
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