ALK (2p23) Break

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref KBI-10747

EMDN W01060205

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-08717973348207 Basic UDI-DI	Date22 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference: KBI-10747

Primary DI / UDI-DI: 08717973348207
Basic UDI-DI: B-08717973348207
EMDN Code: W01060205 C-myc

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: GB-MF-000020595
Authorised representative: AR Experts B.V. NL-AR-000023989

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (8)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED 066c1769-b44d-4129-a264-7c90249e96b2 61 fields · synced 23 Oct 2026