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BASIC-SET COMBILIGHT C10/E15 ophthalmoscope and otoscope
EUDAMEDClass I (EU MDR)
Ref 02.01008.002
Identity
- Trade Name
- BASIC-SET COMBILIGHT C10/E15 ophthalmoscope and otoscope EUDAMED
- Device Name
- Otoscopes and diagnostic sets EUDAMED
- Model / Reference
- 02.01008.002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04030155008213 EUDAMED
- Basic UDI-DI
- 4030155KaWe0101YR EUDAMED
- EMDN Code
- Z12021007,Z12120114 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
BASIC-SET COMBILIGHT C10/E15 ophthalmoscope and otoscope by Kirchner & Wilhelm GmbH + Co KG — 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 | 4030155KaWe0101YR | Class I | Active |
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Manufacturer
- Manufacturer
- Kirchner & Wilhelm GmbH + Co KG
- EUDAMED SRN
- DE-MF-000006338
Sources (1)
- EUDAMED 37516f45-ed74-44e1-8c72-c18ae16d991d 61 fields · synced Jun 18, 2026