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3.5v Practitioner/Fo Diag Set
EUDAMEDClass I (EU MDR)
Ref 1964-P-2004
by Keeler Ltd
Identity
- Trade Name
- 3.5V PRACTITIONER/FO DIAG SET EUDAMED
- Device Name
- Ophthalmic/otologic diagnostic set EUDAMED
- Model / Reference
- 1964-P-2004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272703055 EUDAMED
- Basic UDI-DI
- 5055272745084XR EUDAMED
- Direct Marketing DI
- 05055272703055 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Cyprus 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
3.5v Practitioner/Fo Diag Set 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 61ff5a0e-aadc-4b7a-94c9-ded358c5a804 61 fields · synced Jul 9, 2026