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Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

EUDAMED

Class C (EU MDR)

Ref DH3-192Ref DH3-072Ref DH3-048

by Hangzhou Dalton BioSciences, Ltd.

Identity

Trade Name
Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) EUDAMED
Device Name
Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) EUDAMED
Model / Reference
DH3-192 EUDAMED
DH3-072 EUDAMED
DH3-048 EUDAMED

Identifiers

Primary DI / UDI-DI
06973873140118 EUDAMED
06973873140101 EUDAMED
06973873140019 EUDAMED
Basic UDI-DI
697387314DH3SQ EUDAMED
Direct Marketing DI
06973873140118 EUDAMED
06973873140101 EUDAMED
06973873140019 EUDAMED
EMDN Code
W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Germany 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

New Device

No

EUDAMED

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA) by Hangzhou Dalton BioSciences, Ltd. — Class C — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hangzhou Dalton BioSciences, Ltd.
EUDAMED SRN
CN-MF-000036196
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (3)

  • EUDAMED bbcb12d2-671c-431d-9039-f990c50b4796 61 fields · synced Oct 6, 2026
  • EUDAMED 7bf3a07e-acb7-4690-b3d5-1a8e95ae10bf 61 fields · synced May 18, 2026
  • EUDAMED 853c6922-1d0c-4677-a360-7b74806a4b3a 61 fields · synced May 19, 2026