Identity
- Trade Name
- EarPuffin EUDAMED
- Device Name
- EarPenguin EUDAMED
- Model / Reference
- Otoscope EUDAMEDEPF-001-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429811118126 EUDAMED
- Basic UDI-DI
- 6429811118EarPenguinKP EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
EarPuffin by Sibbo Medical Devices Oy — 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 | 6429811118EarPenguinKP | Class I | Active |
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Manufacturer
- Manufacturer
- Sibbo Medical Devices Oy
- EUDAMED SRN
- FI-MF-000035896
Sources (1)
- EUDAMED 1ab2ad24-e200-46ec-8f48-d63e2d365863 61 fields · synced Aug 3, 2026