Identity
- Trade Name
- RNAscope™ ISH Probe High Risk HPV EUDAMED
- Device Name
- RNAscope™ ISH Probe High Risk HPV EUDAMED
- Model / Reference
- 200450 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-200450LL EUDAMED
- Basic UDI-DI
- B-200450LL EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMEDW01030703 DNA IN SITU HYBRIDISATION REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
RNAscope™ ISH Probe High Risk HPV by Advanced Cell Diagnostics — 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-200450LL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Advanced Cell Diagnostics
- EUDAMED SRN
- US-MF-000047789
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 05b8d457-4c1f-4481-86b3-c2f9dc39ca9a 61 fields · synced Sep 30, 2026
- EUDAMED fdf555b6-7bc8-4081-8081-0729c4aa15b2 61 fields · synced Sep 30, 2026