Identity
- Trade Name
- B-81 EUDAMEDRadioEar A/S FDA UDI
- Generic Name
- Auditory cranial bone vibrator FDA UDI
- Model / Reference
- B-81 EUDAMEDFDA UDI8104119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05711117219586 EUDAMEDFDA UDI
- Basic UDI-DI
- 5711117_P-0000503_RB EUDAMED
- Direct Marketing DI
- 05711117219586 EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z12149080 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Auditory cranial bone vibrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Auditory cranial bone vibrator
RadioEar A/S by Interacoustics A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Auditory cranial bone vibrator.
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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
- Interacoustics A/S
Sources (2)
- FDA UDI de0bd5f6-768f-4214-99c6-634c3195f368 32 fields · synced Jun 18, 2026
- EUDAMED 44fef2b4-7c88-4dc2-8cdc-76713daadf26 61 fields · synced Jun 18, 2026