Skip to content

ICA Control

by Shenzhen Ever-Blue Biotech Co., Ltd. China EUDAMED

Ref ZCC053

EMDN W0102152011

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697388081019P5 Basic UDI-DIDate18 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ZCC053
Primary DI / UDI-DI
06973880813166
Basic UDI-DI
697388081019P5
EMDN Code
W0102152011 Controls for autoimmunity
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025048
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Ever-Blue Biotech Co., Ltd.

See all devices from Shenzhen Ever-Blue Biotech Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED 5344f49e-2ef9-4e2d-9c47-6992bf486cdc 61 fields · synced 22 Oct 2026