Identity
- Trade Name
- Otoscopes EUDAMED
- Device Name
- Otoscopes EUDAMED
- Model / Reference
- TOC-106-003BL EUDAMED
Identifiers
- Primary DI / UDI-DI
- G644TOC106003BL1 EUDAMED
- Basic UDI-DI
- ++G644Otoscopes3F EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Otoscopes by Satellite Industries — 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 | ++G644Otoscopes3F | Class I | Active |
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Manufacturer
- Manufacturer
- Satellite Industries
- EUDAMED SRN
- PK-MF-000041675
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 3e6d84af-85dd-4733-a548-b64f22af5283 61 fields · synced Jul 19, 2026