Identity
- Trade Name
- BXα Plus-13 EUDAMED
- Model / Reference
- BXα Plus-13 EUDAMED101621 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328640279 EUDAMED
- Basic UDI-DI
- 45713286402792M 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-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 | 45713286402792M | 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 d6707d82-3078-4443-b4d4-1e70e03d6e2d 61 fields · synced Jun 18, 2026