KINDvaro 4800 nw
Ref 72022-KINModel Custom
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 | Number0842318172047UZ 00842318196088 | Date16 Jan 2024 | 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- Withdrawn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
- Device Name
- Genesis AI
- Model / Reference
- Custom, 72022-KIN
- Primary DI / UDI-DI
- 00842318196088
- Basic UDI-DI
- 0842318172047UZ
- EMDN Code
- Y2145060204 Hearing aids invisible-in-the-canal (iic)
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000014382
- Authorised representative
- Starkey Laboratories (Germany) GmbH DE-AR-000010831
Other devices from Starkey Laboratories Inc.
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