← Back to catalogue
Cros
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 239288Model CROS/BI-CROS transmitterRef 239285Ref 239283Ref 239282Ref 239287Ref 239284
Identity
- Trade Name
- CROS EUDAMEDOticon FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-the-ear FDA UDI
- Device Name
- OTICON CROS MINIRITE T C092 FDA UDIOTICON CROS MINIRITE T C091 FDA UDIOTICON CROS MINIRITE T C063 FDA UDIOTICON CROS MINIRITE T C094 FDA UDIOTICON CROS MINIRITE T C090 FDA UDIOTICON CROS MINIRITE T C093 FDA UDI
- Model / Reference
- CROS/BI-CROS transmitter EUDAMED239288 EUDAMEDFDA UDI239285 EUDAMEDFDA UDI239283 EUDAMEDFDA UDI239282 EUDAMEDFDA UDI239287 EUDAMEDFDA UDI239284 EUDAMEDFDA UDI
- Description
- OTICON CROS MINIRITE T C092 FDA UDIOTICON CROS MINIRITE T C091 FDA UDIOTICON CROS MINIRITE T C063 FDA UDIOTICON CROS MINIRITE T C094 FDA UDIOTICON CROS MINIRITE T C090 FDA UDIOTICON CROS MINIRITE T C093 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464117772 EUDAMEDFDA UDI05714464117741 EUDAMEDFDA UDI05714464117727 EUDAMEDFDA UDI05714464117710 EUDAMEDFDA UDI05714464117765 EUDAMEDFDA UDI05714464117734 EUDAMEDFDA UDI
- Basic UDI-DI
- 57144640-CROS-00075-KZ EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Market of Registration
- Denmark 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
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, receiver-in-canal
Cros by Sbo Hearing A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-canal.
- SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
- HA EVK E-FS-T USA 440 SLVGR — Widex A/S · Class IIa
- SoniTon UP6 312 trial — Sonova AG · Class IIa
- HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
- HANSATON — Hansaton Akustik GmbH · Class II
- PHONAK — Sonova AG · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-CROS-00075-KZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (12)
- EUDAMED 7a82b53a-f0ec-4016-b18b-1816e1497410 61 fields · synced Aug 3, 2026
- EUDAMED 8bebeb4a-bdcb-4d8c-8ff3-78c8fcbb9cdb 61 fields · synced May 17, 2026
- EUDAMED 154aefe1-a5f2-4fb8-900a-3f7954677f63 61 fields · synced May 17, 2026
- EUDAMED 912ff945-2cab-4460-8ba4-65e60835cf22 61 fields · synced May 17, 2026
- EUDAMED f371dad9-a44d-4574-9850-09efa2503154 61 fields · synced May 18, 2026
- EUDAMED 61575426-9ccf-4784-823a-6c7a50a18237 61 fields · synced May 19, 2026
- FDA UDI 658c167f-10cc-40e7-ba00-789cb660ee57 34 fields · synced May 29, 2026
- FDA UDI 2c026e92-41cb-452f-99f4-011363c5496c 34 fields · synced May 30, 2026
- FDA UDI 2bbd61bd-4c59-4be2-8863-2392e22e4bd9 34 fields · synced May 30, 2026
- FDA UDI fda84e40-052c-4eb6-af31-0f5d6f379200 34 fields · synced May 30, 2026
- FDA UDI 4e149056-6ad2-4a9c-9435-96e84f63e018 34 fields · synced May 30, 2026
- FDA UDI 2dbacb75-c571-433b-9723-c34e018577d4 34 fields · synced May 30, 2026