Identity
- Trade Name
- GN Hearing FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- HI,EP161,RIE,CHMPN FDA UDI
- Model / Reference
- 22420075 EUDAMEDFDA UDIRIE EUDAMED
- Description
- HI,EP161,RIE,CHMPN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05708296254811 EUDAMEDFDA UDI
- Basic UDI-DI
- 57082960000102W 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-canal 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
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: Air-conduction hearing aid, receiver-in-canal
GN Hearing by Gn Hearing A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Gn Hearing A/S
Sources (2)
- FDA UDI fe7b031e-e2f1-4771-8832-4e7977c04f47 34 fields · synced Oct 8, 2026
- EUDAMED 430f6567-70c0-4f1c-ad5e-7921e1364b9f 61 fields · synced Oct 8, 2026