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ALK/ROS1/MET gene fusions and mutations digital PCR detection kit

EUDAMED

Class IVD General (EU MDR)

Ref "Model: AR01-Q16; Specification: 16 Tests Model: AR01-Y16; Specification: 16 Tests"Model AR01-Q16， AR01-Y16;Ref 12605-1Model AR01-Q16

by TargetingOne Technology (Beijing) Corporation

Identity

Trade Name
ALK/ROS1/MET gene fusions and mutations digital PCR detection kit EUDAMED
Device Name
ALK/ROS1/MET gene fusions and mutations digital PCR detection kit EUDAMED
Model / Reference
AR01-Q16， AR01-Y16; EUDAMED
"Model: AR01-Q16; Specification: 16 Tests Model: AR01-Y16; Specification: 16 Tests" EUDAMED
AR01-Q16 EUDAMED
12605-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06974689626131 EUDAMED
Basic UDI-DI
B-06974689626131 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

ALK/ROS1/MET gene fusions and mutations digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — 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
TargetingOne Technology (Beijing) Corporation
EUDAMED SRN
CN-MF-000028247
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 039a38d2-f095-476e-8055-b0014685236d 61 fields · synced Jun 19, 2026
  • EUDAMED 039a38d2-f095-476e-8055-b0014685236d-1 61 fields · synced Jun 9, 2026
  • EUDAMED 9c2fff8a-1fbd-4da1-a6f7-0acddfe3d6f7 61 fields · synced Jun 19, 2026