Identity
- Trade Name
- SOFTBAND/12/BL EUDAMED
- Device Name
- Accessories BC5 (contact mini) EUDAMED
- Model / Reference
- 77734634 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120041052217 EUDAMED
- Basic UDI-DI
- 912004105ACC_BC5U2 EUDAMED
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Softband/12/Bl by BHM-Tech Produktionsgesellschaft m.b.H. — Class I — 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 | 912004105ACC_BC5U2 | Class I | Active |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (1)
- EUDAMED 1e817551-b65e-45ea-b180-2b4b5450f6d2 61 fields · synced Jul 28, 2026