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KaWe EUROLIGHT PRO-SET LED ophthalmoscope and otoscope
EUDAMEDClass I (EU MDR)
Ref 02.15008.003
Identity
- Trade Name
- KaWe EUROLIGHT PRO-SET LED ophthalmoscope and otoscope EUDAMED
- Device Name
- Otoscopes and diagnostic sets EUDAMED
- Model / Reference
- 02.15008.003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04030155018816 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
KaWe EUROLIGHT PRO-SET LED 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 d6ba5041-24d9-48b2-82a8-01d90cb4ff3d 61 fields · synced Oct 8, 2026