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Diagnostic Handle, VISIO 5 "Pulse", USB 3.5V
EUDAMEDClass I (EU MDR)
Ref 805-009-35
Identity
- Trade Name
- Diagnostic Handle, VISIO 5 "Pulse", USB 3.5V EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- 805-009-35 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102789816 EUDAMED
- Basic UDI-DI
- 896110278OTOVIS8086A EUDAMED
- EMDN Code
- Z12021007,Z12120114 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
Diagnostic Handle, VISIO 5 "Pulse", USB 3.5V 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 | 896110278OTOVIS8086A | 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 7e0cd26f-3666-45b7-a3fa-58ed93dd1d9a 61 fields · synced Jul 31, 2026