Identity
- Trade Name
- BXα13ARXSPLED EUDAMED
- Device Name
- Ophthalmo-Retinoscope Set EUDAMED
- Model / Reference
- BXα13ARXSPLED EUDAMED101931 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328653316 EUDAMED
- Basic UDI-DI
- 457132865331632 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
Bxα13arxspled 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 | 457132865331632 | 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 c7a8033a-796a-42cd-9dd7-08d208d9a0a4 61 fields · synced Jul 9, 2026