audioboX 12 Kanäle
Ref 51050010Model 51050005
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 | Number42605854142605854101993W 04260585410250 | Date18 Sep 2025 | 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- Withdrawn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
- Trade Name
- audioboX 12 KanäleMERZ audioboX 12 Kanäle
- Device Name
- Merz Audio
- Model / Reference
- 51050005, 51050010
- Primary DI / UDI-DI
- 04260585410250
- Basic UDI-DI
- 42605854142605854101993W, 426058541MERZAudio4D
- Direct Marketing DI
- 04260585410250
- EMDN Code
- Z121401 Audiometers
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000010619
Other devices from Merz Medizintechnik GmbH
Properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No