Identity
- Trade Name
- Fully Automatic IHC Staining System EUDAMED
- Device Name
- Fully Automatic IHC Staining System EUDAMED
- Model / Reference
- CNT360-M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971804561780 EUDAMED
- Basic UDI-DI
- 697180456CNT360HM EUDAMED
- Direct Marketing DI
- 06971804561780 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
Fully Automatic IHC Staining System by Henan Celnovte Biotechnology Co., Ltd. — 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 | 697180456CNT360HM | Class A | Active |
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Manufacturer
- Manufacturer
- Henan Celnovte Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022882
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 6cc17711-57c1-4a7f-8e37-56b22112e319 61 fields · synced Jun 18, 2026