Identity
- Trade Name
- AN-Evo1 EUDAMEDFDA UDI
- Generic Name
- Head-worn bone-conduction hearing aid FDA UDI
- Device Name
- AN-Evo1 EUDAMEDAN-Evo1, left, brown, bone-conduction hearing system FDA UDI
- Model / Reference
- AN-Evo1/L/BR EUDAMEDFDA UDI77733103 EUDAMED
- Description
- AN-Evo1, left, brown, bone-conduction hearing system FDA UDI
Identifiers
- Catalog Number
- 77733103 FDA UDI
- Primary DI / UDI-DI
- 09120041050015 EUDAMEDFDA UDI
- Basic UDI-DI
- B-09120041050015 EUDAMED
- 510(k) Number
- K121793 FDA UDI
- FDA Product Code
- LXB FDA UDI
- EMDN Code
- Y21450901 SPECTACLE HEARING AIDS EUDAMED
- GMDN Term
- Head-worn bone-conduction hearing aid FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Market of Registration
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AN-Evo1 by BHM-Tech Produktionsgesellschaft m.b.H. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09120041050015 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (2)
- EUDAMED 2735025d-fcc3-4ad6-9a08-aa0f9cac1a4f 61 fields · synced Jun 19, 2026
- FDA UDI 33a99d11-26d0-4026-88d6-5f9374cf19eb 37 fields · synced May 30, 2026