Identity
- Trade Name
- Mini-Otoscope BLACK EUDAMED
- Device Name
- Mini-Otoscope BLACK EUDAMED
- Model / Reference
- M01-091-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G410M01091020 EUDAMED
- Basic UDI-DI
- ++G410M0109102QX EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Category: Otoscope, endoscopic
Mini-Otoscope BLACK by Mehrish Industries Pvt Ltd — 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 | ++G410M0109102QX | Class I | Active |
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Manufacturer
- Manufacturer
- Mehrish Industries Pvt Ltd
- EUDAMED SRN
- PK-MF-000031501
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 90324d37-ffc9-4356-a714-1d35a1c5fb1c 61 fields · synced Jun 19, 2026