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MeltArray High Risk HPV Genotyping Assay
EUDAMEDClass IVD General (EU MDR)
Ref 801943
Identity
- Trade Name
- MeltArray High Risk HPV Genotyping Assay EUDAMED
- Device Name
- MeltArray High Risk HPV Genotyping Assay EUDAMED
- Model / Reference
- 801943 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299703792 EUDAMED
- Basic UDI-DI
- B-06956299703792 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 by Xiamen Zeesan Biotech Co., Ltd. — 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-06956299703792 | 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 ee13e1e2-69a2-44d3-91b9-0e8747cd6fea 61 fields · synced Jun 18, 2026