Identity
- Trade Name
- BXα Plus-13A EUDAMED
- Model / Reference
- BXα Plus-13A EUDAMED101651 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328640286 EUDAMED
- Basic UDI-DI
- 45713286402862J EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I 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 Plus-13A 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 | 45713286402862J | 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 (1)
- EUDAMED 357f9ca2-1007-436a-a720-4a1420b0d819 61 fields · synced Jul 14, 2026