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VivoSight Dx Standoff
EUDAMEDClass IIa (EU MDR)
Ref 1191.MD.317Model VIVOSIGHT DX STANDOFF SET V2 (accessories)
Identity
- Trade Name
- VivoSight Dx Standoff EUDAMED
- Device Name
- VIVOSIGHT DX STANDOFF SET V2 (accessories) EUDAMED
- Model / Reference
- VIVOSIGHT DX STANDOFF SET V2 (accessories) EUDAMED1191.MD.317 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060507260036 EUDAMED
- Basic UDI-DI
- 506050726STANDOFFW9 EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa 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
VivoSight Dx Standoff by Michelson Diagnostics Limited — Class IIa — 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 | 506050726STANDOFFW9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Michelson Diagnostics Limited
- EUDAMED SRN
- GB-MF-000021788
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (1)
- EUDAMED 54e24361-88ab-472c-af41-6b16d174e4d3 61 fields · synced Jul 9, 2026