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High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-F…

EUDAMED

Class IVD General (EU MDR)

Ref TD-0413-02-25Ref TD-0413-02-100Ref TD-0413-02-50

by Shanghai Zj Bio-Tech Co., Ltd

Identity

Trade Name
High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence) EUDAMED
Device Name
High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-Fluorescence) EUDAMED
Model / Reference
TD-0413-02-25 EUDAMED
TD-0413-02-100 EUDAMED
TD-0413-02-50 EUDAMED

Identifiers

Primary DI / UDI-DI
06971042228612 EUDAMED
06971042228636 EUDAMED
06971042228629 EUDAMED
Basic UDI-DI
B-06971042228612 EUDAMED
B-06971042228636 EUDAMED
B-06971042228629 EUDAMED
EMDN Code
W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France 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

High-Risk Human Papillomavirus ( HPV) and Genotyping 16&18 Diagnostic Kit(PCR-F… by Shanghai Zj Bio-Tech Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shanghai Zj Bio-Tech Co., Ltd
EUDAMED SRN
CN-MF-000017861
Authorised Representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (3)

  • EUDAMED 49cf0882-7aac-4566-95fb-1459a7e048c6 61 fields · synced Oct 6, 2026
  • EUDAMED dd41e304-294c-4d2f-bf7b-66a11996fbdc 61 fields · synced May 17, 2026
  • EUDAMED 03d9c736-f7d3-4c1c-8915-f3a1a7db4c16 61 fields · synced May 18, 2026