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MeltArray High Risk HPV Genotyping Assay (Sanity)
EUDAMEDClass IVD General (EU MDR)
Ref 801946
Identity
- Trade Name
- MeltArray High Risk HPV Genotyping Assay (Sanity) EUDAMED
- Device Name
- MeltArray High Risk HPV Genotyping Assay (Sanity) EUDAMED
- Model / Reference
- 801946 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299703808 EUDAMED
- Basic UDI-DI
- B-06956299703808 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
MeltArray High Risk HPV Genotyping Assay (Sanity) by Xiamen Zeesan Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06956299703808 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013246
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 0bc7eeb1-ebb4-4e4e-b2cb-a9c38b990b22 61 fields · synced Jul 15, 2026