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Phonak CROS I-R
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 050-1043-1AModel Sonova CROS device
by Sonova AG
Identity
- Trade Name
- Phonak CROS I-R (copper) EUDAMEDPhonak CROS I-R FDA UDI
- Generic Name
- Contralateral hearing unit FDA UDI
- Device Name
- Sonova CROS device EUDAMED
- Model / Reference
- Sonova CROS device EUDAMED050-1043-1A EUDAMED(copper) FDA UDI
Identifiers
- Catalog Number
- 050-1043-1A FDA UDI
- Primary DI / UDI-DI
- 07613389699142 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389CROSP2 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Contralateral hearing unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Contralateral hearing unit
Phonak CROS I-R by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Contralateral hearing unit.
- Amplifon — WS Audiology USA, Inc. · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- Widex — Widex A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sonova AG
Sources (2)
- FDA UDI 88fbf365-aebd-491f-bccb-e5a60ff0bc93 33 fields · synced Jun 11, 2026
- EUDAMED 6bdc971f-697b-4e56-8c96-63d392d5996f 61 fields · synced Jun 11, 2026