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Sterilization Indicartor Card/Strip

by Anhui KC Medical Technology Co., Ltd

Ref AutoclaveModel Autoclave，Steam，EO，ETO，Plasma，Fornaldehyde，Dry heat，Gamma/E-beam，Class 1，Class 2，Class 4，CLass 5，Class 6

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 Number698024448SPRTL Basic UDI-DI 06980244480001UDI-DIDate1 Jul 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  • Withdrawn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
Sterilization Indicartor Card/Strip
Model / Reference
Autoclave，Steam，EO，ETO，Plasma，Fornaldehyde，Dry heat，Gamma/E-beam，Class 1，Class 2，Class 4，CLass 5，Class 6, Autoclave
Primary DI / UDI-DI
06980244480001
Basic UDI-DI
698024448SPRTL
EMDN Code
S0199 Devices for sterilisation and packaging (excluding cat. d - z) - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000056470
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Anhui KC 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