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Snapshot 2026-10-12 · Link to EUDAMED

Legacy device

Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

UDI-DI 06972665701087Basic UDI-DI B-06972665701087

Unknown class · IVDD (legacy) · XIAMEN SPACEGEN CO.,LTD.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Manufacturer

XIAMEN SPACEGEN CO.,LTD.

SRN CN-MF-000018018

CN · Xiamen

manufacturer

Authorised representative: Lotus NL B.V. (NL-AR-000000121)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/human-bcr-abl-gene-t315i-mutation-detection-kit-multiplex-fl-1087 · UDI page: /udi/06972665701087

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