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OptraSCAN Digital Pathology System

EUDAMED

Class A (EU MDR)

Ref OSDPS-OS-LITE-SYSTEMModel OS-Ultra System, OS-Lite System, OS-SiX System, OS-FS System, OS-Fli SystemRef OSDPS-IMAGEPATHModel ImagePath

by OptraSCAN Inc.

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 EUDAMED
OSDPS-OS-LITE-SYSTEM EUDAMED
ImagePath EUDAMED
OSDPS-IMAGEPATH EUDAMED

Identifiers

Primary DI / UDI-DI
00860015108111 EUDAMED
00860015108166 EUDAMED
Basic UDI-DI
08600151081OSDIGIPATHSY3Y EUDAMED
08600151081IMAGEPATHV6 EUDAMED
Direct Marketing DI
00860015108111 EUDAMED
00860015108166 EUDAMED
EMDN Code
W0202050304 DIGITAL LABORATORY MICROSCOPES EUDAMED

Classification

Device Class
Class A EUDAMED
Special Device Type
Software 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

EUDAMEDEUDAMED

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

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Manufacturer

Manufacturer
OptraSCAN Inc.
EUDAMED SRN
US-MF-000051112
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (2)

  • EUDAMED 7adbd4af-051d-4f54-b1d6-50b79d688fe2 61 fields · synced Jul 25, 2026
  • EUDAMED 981a7e65-c17a-46d3-b1c5-a22ec28b4f37 61 fields · synced May 18, 2026