Additionsvernetzendes Ohrabformsilikon
by Innovation MediTech GmbH 13 variants
Ref 206411
Active
CE MDR
Valid until
4 Dec 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++E2390057YK +E2392064111 | Date12 May 2026 | StatusActive |
Certificates
- 44911220478 Active
Quality management system EU MDR
- Certifier
- TÜV NORD CERT GmbH 0044
- Issued
- 17 Nov 2025
- Expires
- 4 Dec 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Additionsvernetzendes Ohrabformsilikon
- Model / Reference
- 206411
- Primary DI / UDI-DI
- +E2392064111
- Basic UDI-DI
- ++E2390057YK
- EMDN Code
- Y214580 Hearing aids or hearing devices - accessories
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005462
Other devices from Innovation Meditech 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