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3.6v Professional Ophthalmoscope - Oph500
EUDAMEDClass I (EU MDR)
Ref 1128-P-1020
by Keeler Ltd
Identity
- Trade Name
- 3.6V PROFESSIONAL OPHTHALMOSCOPE - OPH500 EUDAMED
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 1128-P-1020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272716314 EUDAMED
- Basic UDI-DI
- 50552727OPHTHALMOSCOPES39 EUDAMED
- Direct Marketing DI
- 05055272716314 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Professional Ophthalmoscope - Oph500 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 | 50552727OPHTHALMOSCOPES39 | 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 a10905c2-308f-4c48-8055-4a5b915477f6 61 fields · synced Jun 18, 2026