Identity
- Trade Name
- OMNI 3000 Pocket Light in Box EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 808-464-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102785030 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
Category: Otoscope, endoscopic
OMNI 3000 Pocket Light in Box by Medical Devices (Pvt) Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Otoscope, endoscopic.
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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 | 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 0c361e63-1412-424d-b347-7abba272e537 61 fields · synced Jul 25, 2026