HER-2 DNA Probe Kit

by Gold Probe Diagnostic Biotechnology Inc. MF China EUDAMED

Ref 600200

EMDN W01060213

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975977072005 Basic UDI-DI	Date19 Dec 2023Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: HER-2 DNA Probe Kit
Model / Reference: 600200

Primary DI / UDI-DI: 06975977072005
Basic UDI-DI: B-06975977072005
EMDN Code: W01060213 Her-2/neu (breast cancer)

Device Class: Class IVD General
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000031524
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Near-Patient Testing
Professional Testing

Other properties (6)

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

Sources (1)

EUDAMED a9693642-18e2-43ae-9e1d-cdc68f71dd7e 61 fields · synced 22 Oct 2026