Skip to content

Sterilization Gusseted Roll

by Sterivic Medical Co., Ltd 2 variants

Ref 300mm*100mModel 50mm*100m、75mm*100m、 100mm*100m、125mm*100m 、135mm*100m、150mm*100m 、200mm*100m、250mm*100m 、300mm*100m、350mm*100m 、380mm*100m、400mm*100m

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 Number6974453750002BQ Basic UDI-DI 06974453750802UDI-DIDate15 Jun 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  • Withdrawn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 Gusseted Roll
Model / Reference
50mm*100m、75mm*100m、 100mm*100m、125mm*100m 、135mm*100m、150mm*100m 、200mm*100m、250mm*100m 、300mm*100m、350mm*100m 、380mm*100m、400mm*100m, 300mm*100m
Primary DI / UDI-DI
06974453750802
Basic UDI-DI
6974453750002BQ
Direct Marketing DI
06974453750802
EMDN Code
S01010101 Sterilisation pouches, flat, paper/plastic film
Device Class
Class I
EU market of registration
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000039428
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sterivic Medical Co., Ltd.

See all devices from Sterivic Medical 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