Identity
- Trade Name
- ISH Kappa Probe EUDAMED
- Device Name
- ISH Kappa Probe EUDAMED
- Model / Reference
- DMRD0579 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927210914047 EUDAMED
- Basic UDI-DI
- B-06927210914047 EUDAMED
- EMDN Code
- W01030703 DNA IN SITU HYBRIDISATION REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ISH Kappa Probe by Shenzhen Dartmon Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06927210914047 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dartmon Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED ecee05e8-e9af-49a3-8563-796343b974ef 61 fields · synced Oct 10, 2026