HercepTest for Automated Link Platforms

by Agilent Technologies Singapore (International) Pte Ltd Singapore EUDAMED

Ref SK00121-2Model SK001 EMDN W0102030301

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-SGMF000014448SK00121A2 Basic UDI-DI	Date20 Aug 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Withdrawn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: SK001, SK00121-2

Primary DI / UDI-DI: D-SGMF000014448SK00121A2
Basic UDI-DI: B-SGMF000014448SK00121A2
EMDN Code: W0102030301 Her-2/neu

Device Class: Class IVD General
Market of Registration: Denmark

Manufacturer details

EUDAMED SRN: SG-MF-000014448
Authorised representative: Agilent Technologies Denmark ApS DK-AR-000001443

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Properties & raw data

Show properties, registry sources and raw records

Professional Testing
Companion Diagnostics

Other properties (8)

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

Sources (1)

EUDAMED 65b69ff3-42f5-4e80-8887-ca7160a57e85 61 fields · synced 23 Oct 2026