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Otoscope Set, OMNI 3000 Delux, WOSB, Purple Color
EUDAMEDClass I (EU MDR)
Ref 808-452-52
Identity
- Trade Name
- Otoscope Set, OMNI 3000 Delux, WOSB, Purple Color EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 808-452-52 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964000576595 EUDAMED
- Basic UDI-DI
- 896110278OTOPOC8082E 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
Otoscope Set, OMNI 3000 Delux, WOSB, Purple Color by Medical Devices (Pvt) Ltd — 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 | 896110278OTOPOC8082E | Class I | Active |
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Manufacturer
- Manufacturer
- Medical Devices (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000021845
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED cfa3273e-2411-4167-8288-eb45b6578463 61 fields · synced Oct 6, 2026