← Back to catalogue

Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit

EUDAMED

Class IVD General (EU MDR)

Ref TD-0031-02Ref TD-0031-04

by Shanghai Zj Bio-Tech Co., Ltd

Identity

Trade Name
Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit EUDAMED
Uterine Cervix Cancer of High-risk HPV Genotype Related  Real Time PCR Kit EUDAMED
Device Name
Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit EUDAMED
Uterine Cervix Cancer of High-risk HPV Genotype Related  Real Time PCR Kit EUDAMED
Model / Reference
TD-0031-02 EUDAMED
TD-0031-04 EUDAMED

Identifiers

Primary DI / UDI-DI
06971042228537 EUDAMED
06971042228544 EUDAMED
Basic UDI-DI
B-06971042228537 EUDAMED
B-06971042228544 EUDAMED
EMDN Code
W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
W0105041002 SCREENING 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

Uterine Cervix Cancer of High-risk HPV Genotype Related Real Time PCR Kit by Shanghai Zj Bio-Tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (2)

  • EUDAMED 54bf8705-5181-4fe9-abd4-a3921b4f63e3 61 fields · synced Oct 6, 2026
  • EUDAMED 942b39d4-52c4-4eff-abbd-1c1085491618 61 fields · synced May 18, 2026