Identity
- Trade Name
- BXα-13 EUDAMEDBXα-13A EUDAMED
- Model / Reference
- BXα-13 EUDAMED101021 EUDAMEDBXα-13A EUDAMED101041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328640019 EUDAMED04571328640033 EUDAMED
- Basic UDI-DI
- 4571328640019ZN EUDAMED4571328640033ZG EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Bxα-13 by Neitz Instruments Co., Ltd. — 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 | 4571328640019ZN | Class I | Active |
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Manufacturer
- Manufacturer
- Neitz Instruments Co., Ltd.
- EUDAMED SRN
- JP-MF-000048706
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2231cfeb-dda1-4ef0-a375-d6dd1ed9ccdf 61 fields · synced Jul 25, 2026
- EUDAMED 30de174d-3550-4382-981e-c1ec9aa7d4aa 61 fields · synced May 19, 2026