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3.6v Prof Streak Led Retinoscope Bundle
EUDAMEDClass I (EU MDR)
Ref 1427-P-1136
by Keeler Ltd
Identity
- Trade Name
- 3.6V PROF STREAK LED RETINOSCOPE BUNDLE EUDAMED
- Device Name
- Retinoscope EUDAMED
- Model / Reference
- 1427-P-1136 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272721585 EUDAMED
- Basic UDI-DI
- 50552727RETINOSCOPESD7 EUDAMED
- Direct Marketing DI
- 05055272721585 EUDAMED
- EMDN Code
- Z12120118 RETINOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
3.6v Prof Streak Led Retinoscope Bundle by Keeler 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 | 50552727RETINOSCOPESD7 | Class I | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- EUDAMED SRN
- GB-MF-000009031
- Authorised Representative
- Keeler Europe Distribution, S.L. ES-AR-000001559
Sources (1)
- EUDAMED c664ff24-29a8-4c1e-9c20-c077602e6421 61 fields · synced Jul 29, 2026