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Iso File, Genie Medical Bahs 2023.1 Us Va
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 256950
Identity
- Trade Name
- ISO FILE, GENIE MEDICAL BAHS 2023.1 US VA EUDAMEDPonto FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Genie Medical BAHS EUDAMEDISO FILE, GENIE MEDICAL BAHS 2023.1 US VA FDA UDI
- Model / Reference
- 256950 EUDAMEDFDA UDI
- Description
- ISO FILE, GENIE MEDICAL BAHS 2023.1 US VA FDA UDI
Identifiers
- Catalog Number
- 256950 FDA UDI
- Primary DI / UDI-DI
- 05712149027255 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491000284 EUDAMED
- Direct Marketing DI
- 05712149027255 EUDAMED
- FDA Product Code
- LXB FDA UDI
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Special Device Type
- Software 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Iso File, Genie Medical Bahs 2023.1 Us Va by Oticon Medical AB — 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 | 57121491000284 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED e84870b5-77fb-41ca-ac6c-10c41982a377 61 fields · synced Jun 18, 2026
- FDA UDI 48af6352-52a2-48ef-8ce2-026e402469a4 34 fields · synced May 30, 2026