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Biological indicators

by Huzhou Icon Medical Technology Co., Ltd. 76 variants

Ref UGBI0206Model SZR5M-6，SZR10M-6,UGBI0206,FCBI0206, RCBI0206,SZR20M-6，SZRB20M-6,UGBI0201, FCBI0201,RCBI0201,SZR1-6，SZRB1-6， UGBI0101,FCBI0101,RCBI0101,SZR3-6， UGBI0301,FCBI0301,RCBI0301,SZ-6，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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698048792BI001FS Basic UDI-DI 06980487920029UDI-DIDate9 Sep 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Biological indicators
Model / Reference
SZR5M-6，SZR10M-6, UGBI0206, FCBI0206, RCBI0206, SZR20M-6，SZRB20M-6, UGBI0201, FCBI0201, RCBI0201, SZR1-6，SZRB1-6， UGBI0101, FCBI0101, RCBI0101, SZR3-6， UGBI0301, FCBI0301, RCBI0301, SZ-6，etc.
Primary DI / UDI-DI
06980487920029
Basic UDI-DI
698048792BI001FS
EMDN Code
S9080 Devices for sterilisation (excluding cat. d - z) - accessories
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000058515
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Huzhou Icon Medical Technology Co., Ltd.

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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