Identity
- Trade Name
- VarioView EUDAMEDFDA UDI
- Generic Name
- Medical monitor/light mount FDA UDI
- Device Name
- Monitorträger Vista und VarioView EUDAMED
- Model / Reference
- VarioView EUDAMEDVV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061591000257 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061591000875SJ EUDAMED
- Direct Marketing DI
- 04061591000257 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical monitor/light mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
VarioView by Ondal Medical Systems Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4061591000875SJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ondal Medical Systems GmbH
- EUDAMED SRN
- DE-MF-000000203
Sources (2)
- EUDAMED 006da9fb-a404-4d34-9932-c9f8f2382aa4 61 fields · synced Jul 29, 2026
- FDA UDI f20ce31d-4305-4a32-b2be-bcf32f195b77 32 fields · synced May 30, 2026