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MFISH Software (requires Karyotyping and FISH Capabilities)
EUDAMEDClass A (EU MDR)
Ref 23SWRMFXDXModel 23GSL10XBFF230DX
Identity
- Trade Name
- MFISH Software (requires Karyotyping and FISH Capabilities) EUDAMED
- Device Name
- CytoVision DX EUDAMED
- Model / Reference
- 23GSL10XBFF230DX EUDAMED23SWRMFXDX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477021058 EUDAMED
- Basic UDI-DI
- 08498320358U 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
MFISH Software (requires Karyotyping and FISH Capabilities) by Leica Biosystems Imaging, Inc. — Class A — IVDR — listed in EUDAMED
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 0e7f8eed-ecee-4f6d-8160-e31ae57ff863 61 fields · synced Jun 19, 2026