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Bio-INSTANT

by Hangzhou ELIT Biotech Co., Ltd.

Ref FIC-H3

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697666795FIC-H3TJ Basic UDI-DI 06976667950054UDI-DIDate29 May 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  • Withdrawn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
Fic-H3
Model / Reference
FIC-H3
Primary DI / UDI-DI
06976667950054
Basic UDI-DI
697666795FIC-H3TJ
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000043511
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hangzhou ELIT Biotech Co., Ltd.

Properties

  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument

Other properties (8)

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