Helene
by Andanza GmbH Germany EUDAMED
Ref K1010H
EMDN M9099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4260322K1010HZ6 | Date24 Jul 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Helene
- Model / Reference
- K1010H
- Primary DI / UDI-DI
- 04260322419119
- Basic UDI-DI
- 4260322K1010HZ6
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 04260322419119|4260322K1010HZ6