Identity
- Trade Name
- NIKOLAI-57/20/GO EUDAMEDNA FDA UDI
- Generic Name
- Head-worn bone-conduction hearing aid FDA UDI
- Device Name
- Accessories BC2, BC3, BC31 EUDAMEDspectacles front; AN-Evo1; contact star evo1 FDA UDI
- Model / Reference
- 77733167 EUDAMEDNIKOLAI-57/20/GO FDA UDI
- Description
- spectacles front; AN-Evo1; contact star evo1 FDA UDI
Identifiers
- Catalog Number
- 77733167 FDA UDI
- Primary DI / UDI-DI
- 09120041050367 EUDAMEDFDA UDI
- Basic UDI-DI
- 912004105ACC_BC2-BC3XV3 EUDAMED
- 510(k) Number
- K121793 FDA UDI
- FDA Product Code
- LXB FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Head-worn bone-conduction hearing aid FDA UDI
Classification
- Device Class
- Class I 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
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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Nikolai-57/20/Go by BHM-Tech Produktionsgesellschaft m.b.H. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 912004105ACC_BC2-BC3XV3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (2)
- EUDAMED fb03c443-a313-4bcc-8398-ee86a459106c 61 fields · synced Jul 29, 2026
- FDA UDI f027e265-8784-45ae-8bc0-adea7596ffed 36 fields · synced May 27, 2026