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Slimline 2.8v Standard Oto
EUDAMEDClass I (EU MDR)
Ref 1518-P-1001
by Keeler Ltd
Identity
- Trade Name
- SLIMLINE 2.8V STANDARD OTO EUDAMED
- Device Name
- Keeler Otoscopes EUDAMED
- Model / Reference
- 1518-P-1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055272702119 EUDAMED
- Basic UDI-DI
- 50552727OTOSCOPESVJ EUDAMED
- Direct Marketing DI
- 05055272702119 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
Slimline 2.8v Standard Oto 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 f0fc26ad-24d9-4310-b4f0-314d6f8cc438 61 fields · synced Jul 26, 2026