Identity
- Trade Name
- HistoCore CHROMAX ST EUDAMED
- Device Name
- HistoCore CHROMAX ST EUDAMED
- Model / Reference
- 14048677888 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049188227065 EUDAMED
- Basic UDI-DI
- 01040491880486A8 EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
HistoCore CHROMAX ST by Leica Biosystems Nussloch Gmbh — 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 | 01040491880486A8 | Class A | Active |
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Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
- EUDAMED SRN
- DE-MF-000021943
Sources (1)
- EUDAMED c596eadb-9aee-4a4f-b320-39968a6c8d82 61 fields · synced Aug 3, 2026