Identity
- Trade Name
- Otoscope ball for pneumatic EUDAMED
- Device Name
- Otoscopes and diagnostic sets EUDAMED
- Model / Reference
- 01.78502.001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04030155001191 EUDAMED
- Basic UDI-DI
- 4030155KaWe0101YR EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES 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
Category: Otoscope, endoscopic
Otoscope ball for pneumatic by Kirchner & Wilhelm GmbH + Co KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 96782fea-4d99-416a-868d-d787811a602a 61 fields · synced Jun 18, 2026