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3.6v Standard Diagnostic Set
EUDAMEDClass I (EU MDR)
Ref 1964-P-2003
by Keeler Ltd
Identity
- Trade Name
- 3.6V STANDARD DIAGNOSTIC SET EUDAMED
- Device Name
- Ophthalmic/otologic diagnostic set EUDAMED
- Model / Reference
- 1964-P-2003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272703048 EUDAMED
- Basic UDI-DI
- 5055272745084XR EUDAMED
- Direct Marketing DI
- 05055272703048 EUDAMED
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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 Standard Diagnostic 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 914b5b3b-7ac0-4bee-8fbf-d371bb01b536 61 fields · synced Jun 17, 2026