HCG Pregnancy Test (Colloidal Gold)

by Anhui Deepblue Medical Technology Co., Ltd EUDAMED

Active European Union

Ref HCG1UST -1Model Cassette Strip Midstream

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-06952062770688 Basic UDI-DI	Date17 Jun 2026Registered	StatusActive
European Union	CE/IVDD	NumberB-06952062770688 Basic UDI-DI	Date17 Jun 2026Registered	StatusActive
European Union	CE/IVDR	NumberV76 003706 0007	Date14 Aug 2025Issued	StatusActive expires 13 Aug 2030

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates

1 certificate · EUDAMED

V76 003706 0007 Issued

Technical documentation EU IVDR

Notified body

TÜV SÜD Product Service GmbH 0123

Issued
14 Aug 2025

Expires
13 Aug 2030

Specification

EUDAMED

Model / Reference: Cassette Strip Midstream, HCG1UST -1

Primary DI / UDI-DI: 06952062770688
Basic UDI-DI: B-06952062770688, 69520627J001KW
EMDN Code: W0102050205 Total human chorionic gonadotropin

Device Class: Class IVD General
Class B
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000018785
Authorised representative: Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

Animal Tissues
Reagent
Self Testing
Professional Testing

Other properties (7)

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