Leica HER2 FISH System - 30 Test

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref TA9217 EMDN W01060213

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-05055331319005 Basic UDI-DI	Date24 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Withdrawn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 · synced 22 Oct 2026

Device Name: Leica HER2 FISH System
Model / Reference: TA9217

Primary DI / UDI-DI: 05055331319005
Basic UDI-DI: B-05055331319005
EMDN Code: W01060213 Her-2/neu (breast cancer)

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

Animal Tissues
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED b024ba98-7a06-421e-960f-57b63aa364bf 61 fields · synced 22 Oct 2026