Identity
- Trade Name
- LOLA-46/16-RT/PI EUDAMED
- Device Name
- Accessories BC2, BC3, BC31 EUDAMED
- Model / Reference
- 77735811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120041059865 EUDAMED
- Basic UDI-DI
- 912004105ACC_BC2-BC3XV3 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
Lola-46/16-Rt/Pi 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_BC2-BC3XV3 | Class I | Active |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (1)
- EUDAMED b3faefe3-76dd-48ce-8d25-600e5d954cfa 61 fields · synced Jul 29, 2026