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3.6v Streak Led Retinoscope & Specialist Ophthalmoscope
EUDAMEDClass I (EU MDR)
Ref 1427-P-1104
by Keeler Ltd
Identity
- Trade Name
- 3.6V STREAK LED RETINOSCOPE & SPECIALIST OPHTHALMOSCOPE EUDAMED
- Device Name
- Ophthalmic/otologic diagnostic set EUDAMED
- Model / Reference
- 1427-P-1104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272713078 EUDAMED
- Basic UDI-DI
- 5055272745084XR EUDAMED
- Direct Marketing DI
- 05055272713078 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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 Streak Led Retinoscope & Specialist Ophthalmoscope 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 | 5055272745084XR | 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 ed04e3d0-e739-44ca-a080-288014cdf9de 61 fields · synced Jul 8, 2026