Identity
- Trade Name
- RX3SPLED EUDAMED
- Device Name
- Retinoscope EUDAMED
- Model / Reference
- RX3SPLED EUDAMED109801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328653255 EUDAMED
- Basic UDI-DI
- 457132865325537 EUDAMED
- EMDN Code
- Z12120118 RETINOSCOPES 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
Rx3spled 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 | 457132865325537 | 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 3632ad7b-e9aa-4b5a-82f6-324447334810 61 fields · synced Jun 18, 2026