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PIK3CA mutation digital PCR detection kit

EUDAMED

Class IVD General (EU MDR)

Ref Model: PI01-Q24; Specification: 24 Tests Model: PI01-Y24; Specification: 24 TestsModel PI01-Q24,PI01-Y24Ref 12545-1Model PI01-Q24

by TargetingOne Technology (Beijing) Corporation

Identity

Trade Name
PIK3CA mutation digital PCR detection kit EUDAMED
Device Name
PIK3CA mutation digital PCR detection kit EUDAMED
Model / Reference
PI01-Q24,PI01-Y24 EUDAMED
Model: PI01-Q24; Specification: 24 Tests Model: PI01-Y24; Specification: 24 Tests EUDAMED
PI01-Q24 EUDAMED
12545-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06974689626094 EUDAMED
Basic UDI-DI
B-06974689626094 EUDAMED
EMDN Code
W010699 GENETIC TESTS - OTHER EUDAMED
W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands EUDAMED
Austria 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

PIK3CA mutation digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
TargetingOne Technology (Beijing) Corporation
EUDAMED SRN
CN-MF-000028247
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 6bf52437-9c33-454d-b5f7-65e51782ec47 61 fields · synced Jun 19, 2026
  • EUDAMED 6bf52437-9c33-454d-b5f7-65e51782ec47-1 61 fields · synced Jun 10, 2026
  • EUDAMED 07697fb1-254b-4e4b-8d70-4ecdf56b582d 61 fields · synced Jun 19, 2026