No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

Legacy device

Dr. PCR™ BCR-ABL1 Major IS Detection Kit

UDI-DI 08809740940087Basic UDI-DI B-08809740940087

Unknown class · IVDD (legacy) · OPTOLANE Technologies Inc.

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Identification

Model: DON01-X
EMDN: W01060208
Issuing agency: GS1
Device status: active
Sterile: No

Manufacturer

OPTOLANE Technologies Inc.

SRN KR-MF-000026042

KR · Yongin-si

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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/dr-pcrtm-bcr-abl1-major-is-detection-kit-0087 · UDI page: /udi/08809740940087

All devices from OPTOLANE Technologies Inc.

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