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AURICAL Loudspeaker
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 8-62-45200Model 8‑62‑45200
Identity
- Trade Name
- AURICAL Loudspeaker EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Air-conduction hearing aid, wearable case FDA UDI
- Device Name
- AURICAL Loudspeaker EUDAMED1081, LOUDSPEAKER FDA UDI
- Model / Reference
- 8‑62‑45200 EUDAMED8-62-45200 EUDAMED1081, LOUDSPEAKER FDA UDI
- Description
- 1081, LOUDSPEAKER FDA UDI
Identifiers
- Catalog Number
- 8-62-45200 FDA UDI
- Primary DI / UDI-DI
- 05713315001093 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA000675Q EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Air-conduction hearing aid, wearable case FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 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
AURICAL Loudspeaker by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5713315NA000675Q | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED 1d37a408-84ba-48b0-a44c-ce42ed69e648 61 fields · synced Jun 19, 2026
- FDA UDI f6eb05bb-3818-49bd-934c-226f1ba90783 34 fields · synced May 30, 2026