Identity
- Trade Name
- Hearbow for ADHEAR EUDAMED
- Device Name
- Hearbow EUDAMED
- Model / Reference
- 77736096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120041056888 EUDAMED
- Basic UDI-DI
- 912004105HBL9 EUDAMED
- Direct Marketing DI
- 09120041056888 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
Hearbow for ADHEAR 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 | 912004105HBL9 | Class I | Active |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (1)
- EUDAMED b1a35a34-c420-44b9-b58d-57e4be24bdb4 61 fields · synced Jun 18, 2026