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Standard Ophth + Led Module
EUDAMEDClass I (EU MDR)
Ref 1126-P-5005
by Keeler Ltd
Identity
- Trade Name
- STANDARD OPHTH + LED MODULE EUDAMED
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 1126-P-5005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272718684 EUDAMED
- Basic UDI-DI
- 50552727OPHTHALMOSCOPES39 EUDAMED
- Direct Marketing DI
- 05055272718684 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES 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
Standard Ophth + Led Module 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 636c152a-f01e-48c9-9ada-ddf0ab24f35f 61 fields · synced Jul 15, 2026