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Sterilization Flat Roll

by Sterivic Medical Co., Ltd 5 variants

Ref 250mm*200mModel 50mmX 200m 55mm X200m 75mmX200m 100mm X200m 120mmX200m 125mm X200m 150mm X200m 200mm X200m 250mmX200m 300mmX200m 350mm X200m 400mX 200m 450mm X200m 500mm X200m 600mm X200m

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6974453750001BN Basic UDI-DI 06974453750352UDI-DIDate2 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  • Withdrawn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 Flat Roll
Model / Reference
50mmX 200m 55mm X200m 75mmX200m 100mm X200m 120mmX200m 125mm X200m 150mm X200m 200mm X200m 250mmX200m 300mmX200m 350mm X200m 400mX 200m 450mm X200m 500mm X200m 600mm X200m, 250mm*200m
Primary DI / UDI-DI
06974453750352
Basic UDI-DI
6974453750001BN
Direct Marketing DI
06974453750352
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