Identity
- Trade Name
- DD65v2 EUDAMEDRadioEar A/S FDA UDI
- Generic Name
- Earphone, circumaural FDA UDI
- Model / Reference
- DD65v2 EUDAMEDFDA UDI8520327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05711117228779 EUDAMEDFDA UDI
- Basic UDI-DI
- 5711117_P-0000506_RL EUDAMED
- Direct Marketing DI
- 05711117228779 EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z12149080 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Earphone, circumaural 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: Earphone, circumaural
RadioEar A/S by Interacoustics A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Earphone, circumaural.
- RadioEar A/S — Interacoustics A/S · Class II
- RadioEar A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
- RadioEar A/S — Interacoustics A/S · Class II
- RadioEar A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · Class II
- RadioEar A/S — Interacoustics A/S · Class II
- Sanibel Supply A/S — Interacoustics A/S · 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
- Interacoustics A/S
Sources (2)
- FDA UDI cb039eba-d0e5-400e-9f01-67f9cf0e92ab 33 fields · synced Jul 10, 2026
- EUDAMED d72bf387-746a-4da4-9d36-fd9eb983a1f8 61 fields · synced Jul 10, 2026