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Ophthalmoscope Set, VISIO 5XE Classic, Desktop Charging, 3.5V LED
EUDAMEDClass I (EU MDR)
Ref 805-137-35
Identity
- Trade Name
- Ophthalmoscope Set, VISIO 5XE Classic, Desktop Charging, 3.5V LED EUDAMED
- Device Name
- Ophthalmoscope EUDAMED
- Model / Reference
- 805-137-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964000576502 EUDAMED
- Basic UDI-DI
- 896110278OPHVIS808Y4 EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Ophthalmoscope Set, VISIO 5XE Classic, Desktop Charging, 3.5V LED by Medical Devices (Pvt) Ltd — Class I — MDR — listed in EUDAMED
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 | 896110278OPHVIS808Y4 | 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 b19224a7-4483-4397-a455-c7bab30a5029 61 fields · synced Oct 6, 2026