← Back to catalogue
Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-bas…
EUDAMEDClass IVD General (EU MDR)
Ref S02104T2064
Identity
- Device Name
- Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay) EUDAMED
- Model / Reference
- S02104T2064 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477611 EUDAMED
- Basic UDI-DI
- B-06970895477611 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-06970895477611 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
- EUDAMED SRN
- CN-MF-000001539
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 4b4f8ebf-2076-4ff5-8abd-593b8ea4c9eb 61 fields · synced Jun 18, 2026