Phonak CROS P-R Chestnut
by Sonova AG EUDAMEDGUDID
Active
Ref 050-0860-P4Model Sonova CROS device
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number07613389CROSP2 | Date11 Dec 2022 | StatusActive |
| United States | GUDID listing GUDID | Number07613389442854 | Date2 Jul 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Phonak CROS P-R Chestnut EUDAMEDSonova Brand GUDID
- Generic Name
- Contralateral hearing unit
- Device Name
- Sonova CROS device
- Model / Ref / Catalog
- Sonova CROS device, 050-0860-P4
- Primary DI / UDI-DI
- 07613389442854
- Basic UDI-DI
- 07613389CROSP2
- FDA Product Code
- OSM
- EMDN Code
- Y214580 Hearing aids or hearing devices - accessories
- GMDN Term
- Contralateral hearing unit
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 874.3305
- Market of Registration
- Austria
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000015958
- Authorised representative
- Sonova Deutschland GmbH DE-AR-000006322
Other devices from Sonova AG
Properties
Other properties (21)
- Sterile: No
- Single Use: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No