ROS1 (6q22) Proximal XL

by Leica Biosystems Newcastle Ltd EUDAMED

Active European Union

Ref KBI-XL002

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-08717973349020 Basic UDI-DI	Date22 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: ROS1 (6q22) Break - XL for BOND
Model / Reference: KBI-XL002

Primary DI / UDI-DI: 08717973349020
Basic UDI-DI: B-08717973349020
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

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