Identity
- Trade Name
- RadioEar A/S FDA UDI
- Generic Name
- Auditory cranial bone vibrator FDA UDI
- Model / Reference
- B71 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05711117219159 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Auditory cranial bone vibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Auditory cranial bone vibrator.
- BC-1 — Bhm-Tech Produktionsgesellschaft Mbh · Class II
- Bone Vibrator Cable for USBLite — Intelligent Hearing Systems Corp. · Class II
- Bone Vibrator 300 Ohms — Intelligent Hearing Systems Corp. · Class II
- TransEar — Ear Technology Corporation · Class II
- Bone Vibrator w/ Cable and Headband (B81) — Intelligent Hearing Systems Corp. · Class II
- Bone Vibrator Cable — Intelligent Hearing Systems Corp. · Class II
- Bone Vibrator Peidatric Head Band — Intelligent Hearing Systems Corp. · Class II
- Bone Vibrator Head Band — Intelligent Hearing Systems Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Interacoustics A/S
Sources (1)
- FDA UDI 3952c590-d598-4b0e-be43-3674071cb0e1 32 fields · synced Jun 1, 2026