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TERT/BRAF mutations digital PCR detection kit

EUDAMED

Class IVD General (EU MDR)

Ref "Model: TE01-Q32; Specification: 32 Tests Model: TE01-Y32; Specification: 32 Tests"Model TE01-Q32，TE01-Y32;Ref 12621-1Model TE01-Q32

by TargetingOne Technology (Beijing) Corporation

Identity

Trade Name
TERT/BRAF mutations digital PCR detection kit EUDAMED
Device Name
TERT/BRAF mutations digital PCR detection kit EUDAMED
Model / Reference
TE01-Q32，TE01-Y32; EUDAMED
"Model: TE01-Q32; Specification: 32 Tests Model: TE01-Y32; Specification: 32 Tests" EUDAMED
TE01-Q32 EUDAMED
12621-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06974689626124 EUDAMED
Basic UDI-DI
B-06974689626124 EUDAMED
EMDN Code
W010699 GENETIC TESTS - OTHER EUDAMED
W01060212 TELOMERASE 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

TERT/BRAF mutations 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 f58dfac4-4117-4750-b3ac-9420326d6ace 61 fields · synced Jul 20, 2026
  • EUDAMED f58dfac4-4117-4750-b3ac-9420326d6ace-1 61 fields · synced Jun 10, 2026
  • EUDAMED 88adc327-ef03-4b47-a266-ec25f3ca3631 61 fields · synced Jul 20, 2026