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Tissue Slide Stainer
EUDAMEDClass A (EU MDR)
Ref 020Model KH-S60 KH-S80 KH-S100 KH-S100 KH-S103 KH-S106 KH-S108 KH-F3
Identity
- Trade Name
- TISSUE SLIDE STAINER EUDAMED
- Device Name
- TISSUE SLIDE STAINER EUDAMED
- Model / Reference
- KH-S60 KH-S80 KH-S100 KH-S100 KH-S103 KH-S106 KH-S108 KH-F3 EUDAMED020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977185070200 EUDAMED
- Basic UDI-DI
- 697718507KHTSSUC EUDAMED
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Category: Microscope slide stainer IVD
Tissue Slide Stainer by Xiaogan Kuohai Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697718507KHTSSUC | Class A | Active |
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Manufacturer
- Manufacturer
- Xiaogan Kuohai Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000040038
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 45ca5e60-8f90-4538-929f-28339078a203 61 fields · synced Jun 18, 2026