Identity
- Trade Name
- OMNI 3000 Nasal Illuminator , WSB EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 808-466-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102785047 EUDAMED
- Basic UDI-DI
- 896110278OTOPOC8082E EUDAMED
- EMDN Code
- W0202030202 TRANSILLUMINATORS 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
OMNI 3000 Nasal Illuminator , WSB 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 0ca8109b-19b1-4831-b48c-51de0e1a44eb 61 fields · synced Jul 20, 2026