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SAA Rapid Test

by Zhejiang Anji Saianfu Biotechnology Co., Ltd. China EUDAMED

Ref 3051401

EMDN W01021199

Overview

The SAA Rapid Test is a medical device designed for rapid diagnosis and detection of various diseases, particularly infectious diseases. This portable device uses advanced molecular testing to provide accurate results quickly, making it an ideal tool for healthcare professionals and patients alike.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69743840308518 Basic UDI-DIDate6 Jan 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
3051401
Primary DI / UDI-DI
69743840308518
Basic UDI-DI
B-69743840308518
EMDN Code
W01021199 Rheumatoid / inflammatory disease markers - other
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000045029
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhejiang Anji Saianfu Biotechnology Co., Ltd.

See all devices from Zhejiang Anji Saianfu Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 03abe70d-aff2-4a9e-a912-d5a675d9a7ac 61 fields · synced 24 Oct 2026