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Tissue FISH Software and Joystick - Scan System Only
EUDAMEDClass A (EU MDR)
Ref 23SWRTFHDXModel 23GSL10XBFF230DX
Identity
- Trade Name
- Tissue FISH Software and Joystick - Scan System Only EUDAMED
- Device Name
- CytoVision DX EUDAMED
- Model / Reference
- 23GSL10XBFF230DX EUDAMED23SWRTFHDX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477021065 EUDAMED
- Basic UDI-DI
- 08498320358U EUDAMED
- Direct Marketing DI
- 00815477021065 EUDAMED
- EMDN Code
- W0202050382 LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Tissue FISH Software and Joystick - Scan System Only by Leica Biosystems Imaging, 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 | 08498320358U | Class A | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Imaging, Inc.
- EUDAMED SRN
- US-MF-000020547
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 1a52a83a-cc0c-459b-9829-8a1ba8187265 61 fields · synced Jul 25, 2026