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Sterilization Pouch/Reel

by Anhui KC Medical Technology Co., Ltd

Ref Sterilization Flat ReelModel Sterilization Flat Reel，Sterilization Gusseted Reel，Sterilization Plasma Tyvek Reel，Sterilization Flat Pouch，Sterilization Gusseted Pouch，Flat Pouch，Self-seal pouch

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 Number698024448SP001GG Basic UDI-DI 06980244480131UDI-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  • Withdrawn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 Pouch/Reel
Model / Reference
Sterilization Flat Reel，Sterilization Gusseted Reel，Sterilization Plasma Tyvek Reel，Sterilization Flat Pouch，Sterilization Gusseted Pouch，Flat Pouch，Self-seal pouch, Sterilization Flat Reel
Primary DI / UDI-DI
06980244480131
Basic UDI-DI
698024448SP001GG
EMDN Code
S01010101 Sterilisation pouches, flat, paper/plastic film
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