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Lung cancer digital PCR panel

EUDAMED

Class IVD General (EU MDR)

Ref "Model: LC01-Q12, Specification: 12 Tests Model: LC01-Y12, Specification: 12 Tests"Model LC01-Q12,LC01-Y12,Ref 12682-1Model LC01-Q12

by TargetingOne Technology (Beijing) Corporation

Identity

Trade Name
Lung cancer digital PCR panel EUDAMED
Device Name
Lung cancer digital PCR panel EUDAMED
Model / Reference
LC01-Q12,LC01-Y12, EUDAMED
"Model: LC01-Q12, Specification: 12 Tests Model: LC01-Y12, Specification: 12 Tests" EUDAMED
LC01-Q12 EUDAMED
12682-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06974689626230 EUDAMED
Basic UDI-DI
B-06974689626230 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
Finland 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

Lung cancer digital PCR panel by TargetingOne Technology (Beijing) Corporation — 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

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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 1d7c3a58-7d3a-4d58-8bbd-fb10891796b6 61 fields · synced Jun 19, 2026
  • EUDAMED 1d7c3a58-7d3a-4d58-8bbd-fb10891796b6-1 61 fields · synced Jun 10, 2026
  • EUDAMED f94f6d1a-999b-49f8-9474-431de5cdd6d6 61 fields · synced Jun 19, 2026