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AmoyDx® ROS1 Gene Fusions Detection Kit

EUDAMED

Class IVD General (EU MDR)

Ref 8.01.0022Model 12 tests/kitRef 8.01.0021Ref 8.01.0020Ref 8.01.0165

by Amoy Diagnostics Co., LTD.

Identity

Device Name
AmoyDx® ROS1 Gene Fusions Detection Kit EUDAMED
Model / Reference
12 tests/kit EUDAMED
8.01.0022 EUDAMED
8.01.0021 EUDAMED
8.01.0020 EUDAMED
8.01.0165 EUDAMED

Identifiers

Primary DI / UDI-DI
06959094210847 EUDAMED
06959094210830 EUDAMED
06959094210571 EUDAMED
06959094212636 EUDAMED
Basic UDI-DI
B-06959094210847 EUDAMED
B-06959094210830 EUDAMED
B-06959094210571 EUDAMED
B-06959094212636 EUDAMED
EMDN Code
W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Northern Ireland 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

AmoyDx® ROS1 Gene Fusions Detection Kit by Amoy Diagnostics Co., LTD. — 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
Amoy Diagnostics Co., LTD.
EUDAMED SRN
CN-MF-000021843
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (4)

  • EUDAMED 19391524-9b92-4c2d-8661-1a3643b7cc17 61 fields · synced Aug 1, 2026
  • EUDAMED 799839a4-8e82-4211-a5ba-61e575c456e4 61 fields · synced May 17, 2026
  • EUDAMED 7c369b82-7177-4325-af2b-47b17c335c03 61 fields · synced May 17, 2026
  • EUDAMED 6e91103d-8869-4052-9a4d-1b8b66e3a83f 61 fields · synced May 18, 2026