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Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-bas…
EUDAMEDClass IVD General (EU MDR)
Ref S02104T2096Ref S031T096B0C2Ref S02701T2048Ref S02701T2096Ref S01502T2048Ref S01502T2096Ref S02901T2048
Identity
- Device Name
- Human Papillomavirus nucleic acid amplification test kit (Fluorescent Probe-based real-time PCR assay) EUDAMED
- Model / Reference
- S02104T2096 EUDAMEDS031T096B0C2 EUDAMEDS02701T2048 EUDAMEDS02701T2096 EUDAMEDS01502T2048 EUDAMEDS01502T2096 EUDAMEDS02901T2048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970895477628 EUDAMED06970895475938 EUDAMED06970895475617 EUDAMED06970895476003 EUDAMED06970895477574 EUDAMED06970895477598 EUDAMED06970895475754 EUDAMED06970895475679 EUDAMED06970895475662 EUDAMED
- Basic UDI-DI
- B-06970895477628 EUDAMEDB-06970895475938 EUDAMEDB-06970895475617 EUDAMEDB-06970895476003 EUDAMEDB-06970895477574 EUDAMEDB-06970895477598 EUDAMEDB-06970895475754 EUDAMEDB-06970895475679 EUDAMEDB-06970895475662 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-06970895477628 | 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 (9)
- EUDAMED dec7c763-1891-44fa-8004-016436d9c3b9 61 fields · synced Aug 3, 2026
- EUDAMED 4cd0e0d6-dbaa-44a3-9f07-dd459c9c797b 61 fields · synced May 17, 2026
- EUDAMED 6937315e-2b97-4a94-898a-6c80337a5915 61 fields · synced May 17, 2026
- EUDAMED ae9e2e34-4a7e-49c1-8ed5-d67ce5c1aae9 61 fields · synced May 17, 2026
- EUDAMED ba2282ec-8ab2-4e35-9aa8-e8ab61fc797c 61 fields · synced May 18, 2026
- EUDAMED c873a728-744d-4272-ba35-04151fdfbdc8 61 fields · synced May 18, 2026
- EUDAMED f708c5fa-a286-44d7-a2e6-3d00288a6bd2 61 fields · synced May 18, 2026
- EUDAMED 9f68284f-4d7e-4144-8625-410ac6ea675b 61 fields · synced May 19, 2026
- EUDAMED f2e58a1f-51fa-4eb6-bcc9-5a60ef0af603 61 fields · synced May 19, 2026