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Sales Pack, Genie Medical Bahs 2023.1 Usb
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 254434
Identity
- Trade Name
- SALES PACK, GENIE MEDICAL BAHS 2023.1 USB EUDAMEDPonto FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Genie Medical BAHS EUDAMEDSALES PACK, GENIE MEDICAL BAHS 2023.1 USB FDA UDI
- Model / Reference
- 254434 EUDAMEDFDA UDI
- Description
- SALES PACK, GENIE MEDICAL BAHS 2023.1 USB FDA UDI
Identifiers
- Catalog Number
- 254434 FDA UDI
- Primary DI / UDI-DI
- 05712149027262 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491000284 EUDAMED
- Direct Marketing DI
- 05712149027262 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sales Pack, Genie Medical Bahs 2023.1 Usb 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 1ff3a286-a5db-42a7-969f-7a1a9a4b3219 61 fields · synced Oct 6, 2026
- FDA UDI 18a0a734-f6b7-4a23-863b-fab4ad12e37f 34 fields · synced May 30, 2026