EuroGen Strep A Rapid Test

by GenSure Biotech Inc. China EUDAMED

Ref Y2019C10 EMDN W0105090103

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697683823P201900F9 Basic UDI-DI	Date18 Jul 2025Registered	StatusActive
European Union	CE/IVDR	NumberV76 126886 0005	Date11 Jul 2025Issued	StatusActive expires 10 Jul 2030

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

V76 126886 0005 Issued

Technical documentation EU IVDR

Notified body

TÜV SÜD Product Service GmbH 0123

Issued
11 Jul 2025

Expires
10 Jul 2030

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Strep A Rapid Test
Model / Reference: Y2019C10

Primary DI / UDI-DI: 16976838235383
Basic UDI-DI: 697683823P201900F9
EMDN Code: W0105090103 Strep. a - rt & poc

Device Class: Class C
Market of Registration: Cyprus

Manufacturer details

EUDAMED SRN: CN-MF-000028354
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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EuroGen Strep A Rapid Test

Class C

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Self Testing
Professional Testing
New Device

Other properties (6)

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

Sources (1)

EUDAMED 4852dea1-b719-47d7-9281-d7c6e8d7c546 61 fields · synced 24 Oct 2026