Identity
- Trade Name
- Digital EarPenguin EUDAMED
- Device Name
- EarPenguin EUDAMED
- Model / Reference
- Otoscope EUDAMEDDEP-001-H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429811118027 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
Category: Otoscope, endoscopic
Digital EarPenguin by Sibbo Medical Devices Oy — 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 | 6429811118EarPenguinKP | Class I | Active |
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Manufacturer
- Manufacturer
- Sibbo Medical Devices Oy
- EUDAMED SRN
- FI-MF-000035896
Sources (1)
- EUDAMED 8ef579c1-9970-4568-8051-60807d262634 61 fields · synced Jul 10, 2026