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OptraSCAN Digital Pathology System
EUDAMEDClass A (EU MDR)
Ref OSDPS-OS-FS-SYSTEMModel OS-Ultra System, OS-Lite System, OS-SiX System, OS-FS System, OS-Fli System
Identity
- Trade Name
- OptraSCAN Digital Pathology System EUDAMED
- Device Name
- OptraSCAN Digital Pathology System EUDAMED
- Model / Reference
- OS-Ultra System, OS-Lite System, OS-SiX System, OS-FS System, OS-Fli System EUDAMEDOSDPS-OS-FS-SYSTEM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860015108135 EUDAMED
- Basic UDI-DI
- 08600151081OSDIGIPATHSY3Y EUDAMED
- Direct Marketing DI
- 00860015108135 EUDAMED
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
OptraSCAN Digital Pathology System by OptraSCAN Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08600151081OSDIGIPATHSY3Y | Class A | Active |
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Manufacturer
- Manufacturer
- OptraSCAN Inc.
- EUDAMED SRN
- US-MF-000051112
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 387deb7b-159b-4697-b5bf-ac74b50b9699 61 fields · synced Jun 18, 2026