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PGOTOS Sterilization TYVEK Flat Rolls(IYTR)

by I Yueh Medical Technology Co., Ltd. 4 variants

Ref IYTR-100mmX100M

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471254761MSPKT Basic UDI-DI 04712547611507UDI-DIDate20 Feb 2025RegisteredStatusActive

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  • Withdrawn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
Medical Sterilization Package
Model / Reference
IYTR-100mmX100M
Primary DI / UDI-DI
04712547611507
Basic UDI-DI
471254761MSPKT
EMDN Code
S01020201 Flat sterilisation reels, tyvek/plastic film
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000046258
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from I Yueh Medical Technology Co., Ltd.

See all devices from I Yueh 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