Cochlear® Custom Sound® (v 7.1, Spanish)
Ref P2115117
Active
CE MDR
Valid until
21 Dec 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9321502CustomSoundDE 09321502078405 | Date2 Oct 2026 | StatusActive |
Certificates
- G70 078611 0137 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 23 Sep 2026
- Expires
- 21 Dec 2031
- Valid from
- 22 Dec 2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Custom Sound®
- Model / Reference
- P2115117
- Primary DI / UDI-DI
- 09321502078405
- Basic UDI-DI
- 9321502CustomSoundDE
- EMDN Code
- J0380 Auditory active-implantable devices - accessories
- Device Class
- Class III
- Special Device Type
- Software
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- AU-MF-000009890
- Authorised representative
- Cochlear Deutschland GmbH & Co. KG DE-AR-000006034
Other devices from Cochlear Ltd
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