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Slimline 3.6v Spot Ret & Professional Ophth
EUDAMEDClass I (EU MDR)
Ref 1427-P-1061
by Keeler Ltd
Identity
- Trade Name
- SLIMLINE 3.6V SPOT RET & PROFESSIONAL OPHTH EUDAMED
- Device Name
- Ophthalmic/otologic diagnostic set EUDAMED
- Model / Reference
- 1427-P-1061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272701709 EUDAMED
- Basic UDI-DI
- 5055272745084XR EUDAMED
- Direct Marketing DI
- 05055272701709 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Slimline 3.6v Spot Ret & Professional Ophth 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 b8a24fd7-b536-437d-8554-b73de9c1438c 61 fields · synced Jul 9, 2026