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3.6v Professional Student Set Led Only
EUDAMEDClass I (EU MDR)
Ref 1427-P-1118
by Keeler Ltd
Identity
- Trade Name
- 3.6V PROFESSIONAL STUDENT SET LED ONLY EUDAMED
- Device Name
- Ophthalmic/otologic diagnostic set EUDAMED
- Model / Reference
- 1427-P-1118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272718509 EUDAMED
- Basic UDI-DI
- 5055272745084XR EUDAMED
- Direct Marketing DI
- 05055272718509 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER 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 Professional Student Set Led Only 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 c4d4a5b7-c812-4507-b817-62e53db579aa 61 fields · synced Jun 19, 2026