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Genie Medical BAHS, Sales Pack 2021.2 USB UK
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 226479
Identity
- Trade Name
- Genie Medical BAHS, Sales Pack 2021.2 USB UK EUDAMEDPonto FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Genie Medical BAHS EUDAMEDGenie Medical BAHS 2021.2 USB. ISO file for this software is 5712149026876 FDA UDI
- Model / Reference
- 226479 EUDAMEDFDA UDI
- Description
- Genie Medical BAHS 2021.2 USB. ISO file for this software is 5712149026876 FDA UDI
Identifiers
- Catalog Number
- 226479 FDA UDI
- Primary DI / UDI-DI
- 05712149026807 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491000284 EUDAMED
- Direct Marketing DI
- 05712149026807 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
- Market of Registration
- Sweden 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Genie Medical BAHS, Sales Pack 2021.2 USB UK 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 72fc5162-b2af-484a-be31-226fe435e4a6 61 fields · synced Oct 6, 2026
- FDA UDI 119d8309-53a9-4290-88ea-c8d67dff4ecd 35 fields · synced May 29, 2026