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Tuberculosis Antibody Rapid Test

by Zhuhai Encode Medical Engineering Co., Ltd. China EUDAMED

Ref ITA-812Model 25Tests/Kit EMDN W0105010702

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566302820 Basic UDI-DIDate9 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
25Tests/Kit, ITA-812
Primary DI / UDI-DI
06974566302820
Basic UDI-DI
B-06974566302820
EMDN Code
W0105010702 Mycobacterial antibody assays
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhuhai Encode Medical Engineering Co., Ltd.

See all devices from Zhuhai Encode Medical Engineering Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 8e74a011-7af3-418f-92a5-5aa027cf718d 61 fields · synced 22 Oct 2026