Amplifon App
Ref AMP-APP-001, APP-002
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 | Number805960611APP0017N | Date20 Mar 2023 | 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- Withdrawn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
- Model / Reference
- AMP-APP-001, APP-002
- Primary DI / UDI-DI
- 08059606110011, 08059606110035
- Basic UDI-DI
- 805960611APP0017N, 805960611APP0027Q
- Direct Marketing DI
- 0805960611001108059606110035
- EMDN Code
- Y214599 Hearing aids - other
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- ItalyPortugal
Manufacturer details
- EUDAMED SRN
- IT-MF-000012109
Other devices from Amplifon S.p.A
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