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Karyotyping and FISH Review Software (incl Dongle)
EUDAMEDClass A (EU MDR)
Ref 23SWRBFFDXModel 23GSL10XBFF230DX
Identity
- Trade Name
- Karyotyping and FISH Review Software (incl Dongle) EUDAMED
- Device Name
- CytoVision DX EUDAMED
- Model / Reference
- 23GSL10XBFF230DX EUDAMED23SWRBFFDX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477021041 EUDAMED
- Basic UDI-DI
- 08498320358U EUDAMED
- Direct Marketing DI
- 00815477021041 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
Karyotyping and FISH Review Software (incl Dongle) 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 ee5cf9c8-2c71-4cfd-8c12-337052bc69d3 61 fields · synced Jun 18, 2026