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Karyo FISH Station with Camera (without Microscope)
EUDAMEDClass A (EU MDR)
Ref 23CAP002BFF230DXModel 23GSL10XBFF230DXRef 23CAP003BFF230DX
Identity
- Trade Name
- Karyo FISH Station with Camera (without Microscope) EUDAMEDKaryo FISH Station with Camera (without Microscope and Lamphouse) EUDAMED
- Device Name
- CytoVision DX EUDAMED
- Model / Reference
- 23GSL10XBFF230DX EUDAMED23CAP002BFF230DX EUDAMED23CAP003BFF230DX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477020952 EUDAMED00815477020969 EUDAMED
- Basic UDI-DI
- 08498320358U EUDAMED
- Direct Marketing DI
- 00815477020952 EUDAMED00815477020969 EUDAMED
- EMDN Code
- W0202050304 DIGITAL LABORATORY MICROSCOPES 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
Karyo FISH Station with Camera (without Microscope) 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 (2)
- EUDAMED 54456c08-1ee4-459c-88b6-29d82786c66c 61 fields · synced Jul 14, 2026
- EUDAMED 91bad832-7c78-459c-9292-38841b9931ce 61 fields · synced May 18, 2026