← Back to catalogue
VivoSight Dx Pro
EUDAMEDClass IIa (EU MDR)
Ref DX1302 ProModel VivoSight Dx Pro
Identity
- Trade Name
- VivoSight Dx Pro EUDAMED
- Device Name
- VivoSight Dx Pro Topical OCT System EUDAMED
- Model / Reference
- VivoSight Dx Pro EUDAMEDDX1302 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060507260050 EUDAMED
- Basic UDI-DI
- 506050726DXPRO13025Y EUDAMED
- Direct Marketing DI
- 05060507260050 EUDAMED
- EMDN Code
- Z119099 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - OTHER 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VivoSight Dx Pro 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 | 506050726DXPRO13025Y | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Michelson Diagnostics Limited
- EUDAMED SRN
- GB-MF-000021788
- Authorised Representative
- Medical Device Management Ltd IE-AR-000002496
Sources (1)
- EUDAMED 642ab402-da6a-49a0-8892-bee7fc42a24e 61 fields · synced Jul 13, 2026