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Keeler 2.8v Standard Otoscope
EUDAMEDClass I (EU MDR)
Ref 1516-P-5069
by Keeler Ltd
Identity
- Trade Name
- KEELER 2.8V STANDARD OTOSCOPE EUDAMED
- Device Name
- Keeler Otoscopes EUDAMED
- Model / Reference
- 1516-P-5069 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272717939 EUDAMED
- Basic UDI-DI
- 50552727OTOSCOPESVJ EUDAMED
- Direct Marketing DI
- 05055272717939 EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES 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
Keeler 2.8v Standard Otoscope 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 | 50552727OTOSCOPESVJ | 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 3c221b34-5c4f-4150-bd96-daba10b56240 61 fields · synced Jun 18, 2026