FISH Reagent Kit

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref KBI-60005

EMDN W01030703

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number871797334PTKFRG00007KN Basic UDI-DI	Date22 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference: KBI-60005

Primary DI / UDI-DI: 08717973347491
Basic UDI-DI: 871797334PTKFRG00007KN
Direct Marketing DI: 08717973347491
EMDN Code: W01030703 DNA in situ hybridisation reagents

Device Class: Class A
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 (9)

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

Sources (1)

EUDAMED 03aed073-51ca-458b-9285-3c412444e325 61 fields · synced 24 Oct 2026