Leica HER2 FISH Control Slides

by Leica Biosystems Newcastle Ltd United Kingdom EUDAMED

Ref TA9123 EMDN W01060213

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-05055331319340 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Withdrawn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 23 Oct 2026

Model / Reference: TA9123

Primary DI / UDI-DI: 05055331319340
Basic UDI-DI: B-05055331319340
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

Other devices from Leica Biosystems Newcastle, Limited

Bond PA0265-U

Class I
Bond PA0404-U

Class I
Bond DS9202-U

Class I
Bond PA0678-U

Class I
Bond PA0834-U

Class I
Bond PA0369-U

Class I

See all devices from Leica Biosystems Newcastle, Limited →

Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 6becb735-3401-4b38-b047-e78e6e256326 61 fields · synced 23 Oct 2026