Skip to content

Rapid Readout Biological indicator / Biological indicator

by HUBEI Cfull Medical Technology Co., Ltd 3 variants

Ref CFCS0301Model CFBI0101, CFBI0102, CFBI0103, CFBI0104, CFBI0105, CFBI0106, CFBI0107, CFBI0108, CFBI0109, CFBI0201, CFBI0202, CFBI0203, CFBI0204, CFBI0205, CFBI0206, CFBI0207, CFBI0208, CFBI0209, etc

Active European Union

CE MDR

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/MDR Number697657193BI01MW Basic UDI-DI 06976571930159UDI-DIDate22 Apr 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Rapid Readout Biological indicator / Biological indicator
Model / Reference
CFBI0101, CFBI0102, CFBI0103, CFBI0104, CFBI0105, CFBI0106, CFBI0107, CFBI0108, CFBI0109, CFBI0201, CFBI0202, CFBI0203, CFBI0204, CFBI0205, CFBI0206, CFBI0207, CFBI0208, CFBI0209, etc, CFCS0301
Primary DI / UDI-DI
06976571930159
Basic UDI-DI
697657193BI01MW
EMDN Code
S9099 Sterilisation devices (excluding cat. d - z) - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047208
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Sterilizer/disinfector rack

Other devices from HUBEI Cfull Medical Technology Co., Ltd

See all devices from HUBEI Cfull Medical Technology Co., Ltd →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No