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Bxαrcusbrxspled
EUDAMEDClass I (EU MDR)
Ref 101971Model BXαRCUSBRXSPLEDRef 101961Model BXαRCUSBRXLED
Identity
- Trade Name
- BXαRCUSBRXSPLED EUDAMEDBXαRCUSBRXLED EUDAMED
- Device Name
- Ophthalmo-Retinoscope Set EUDAMED
- Model / Reference
- BXαRCUSBRXSPLED EUDAMED101971 EUDAMEDBXαRCUSBRXLED EUDAMED101961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328653507 EUDAMED04571328653491 EUDAMED
- Basic UDI-DI
- 45713286535073B EUDAMED45713286534913M 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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bxαrcusbrxspled 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 | 45713286535073B | 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 e6d57419-c9a8-4a50-b88b-35ffd4d2da4b 61 fields · synced Jul 28, 2026
- EUDAMED b5cd3335-0c25-4c53-817e-d734ef054e47 61 fields · synced May 18, 2026