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Auto-HFIAS 1000

by Sichuan Xincheng Biological Co LTD

Ref J050210

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69505428J05XQ Basic UDI-DI 06950542822155UDI-DIDate31 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Fluorescent Immunoanalyzer
Model / Reference
J050210
Primary DI / UDI-DI
06950542822155
Basic UDI-DI
69505428J05XQ
Direct Marketing DI
06950542822155
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class A
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
CN-MF-000057614
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Sichuan Xincheng Biological Co LTD

See all devices from Sichuan Xincheng Biological Co LTD →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No