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Karyo FISH Station with Microscope and CameraCamera
EUDAMEDClass A (EU MDR)
Ref 23CAP001BFF230DXModel 23GSL10XBFF230DX
Identity
- Trade Name
- Karyo FISH Station with Microscope and CameraCamera EUDAMED
- Device Name
- CytoVision DX EUDAMED
- Model / Reference
- 23GSL10XBFF230DX EUDAMED23CAP001BFF230DX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815477020938 EUDAMED
- Basic UDI-DI
- 08498320358U EUDAMED
- Direct Marketing DI
- 00815477020938 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 Microscope and CameraCamera 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 437c0692-cc47-4661-bf87-af656678db3d 61 fields · synced Aug 3, 2026