Identity
- Trade Name
- ISO FILE, GENIE MEDICAL BAHS 2022.1 UK EUDAMED
- Device Name
- Genie Medical BAHS EUDAMED
- Model / Reference
- 235655 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05712149026999 EUDAMED
- Basic UDI-DI
- 57121491000284 EUDAMED
- Direct Marketing DI
- 05712149026999 EUDAMED
- EMDN Code
- Z12040282 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Iso File, Genie Medical Bahs 2022.1 Uk by Oticon Medical AB — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57121491000284 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (1)
- EUDAMED 34d000ad-8066-428f-b436-c7bc842c3908 61 fields · synced Jul 9, 2026