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RX head with 4V bulb
EUDAMEDClass I (EU MDR)
Ref 109691Model RX head with 4V bulb
Identity
- Trade Name
- RX head with 4V bulb EUDAMED
- Model / Reference
- RX head with 4V bulb EUDAMED109691 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328640224 EUDAMED
- Basic UDI-DI
- 4571328640224ZR 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
RX head with 4V bulb 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 | 4571328640224ZR | 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 63be618d-124a-415a-a5df-97b7779131e5 61 fields · synced Jul 20, 2026