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Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe-bas…
EUDAMEDClass IVD General (EU MDR)
Ref S021T048B0C2
Identity
- Device Name
- Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe-based Real-time PCR Assay) EUDAMED
- Model / Reference
- S021T048B0C2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477543 EUDAMED
- Basic UDI-DI
- B-06970895477543 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA 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
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
Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe-bas… by Jiangsu Mole Bioscience Co., LTD. — Class IVD General — IVDD — listed in…
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-06970895477543 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 88fb29b6-7c31-4120-b92f-d495f43bded6 61 fields · synced Jun 18, 2026