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RX head with 3V bulb
EUDAMEDClass I (EU MDR)
Ref 109681Model RX head with 3V bulb
Identity
- Trade Name
- RX head with 3V bulb EUDAMED
- Model / Reference
- RX head with 3V bulb EUDAMED109681 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04571328640217 EUDAMED
- Basic UDI-DI
- 4571328640217ZU 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 3V 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 | 4571328640217ZU | 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 d48be48b-e19c-405d-92a5-5b464c28d792 61 fields · synced Jun 19, 2026