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Disposable Sterile Surgical Film

by Shandong Fengao Medical Technology Co., Ltd. EUDAMED

Active European Union

Ref B4550EN

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697067081120JX Basic UDI-DIDate10 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
B4550EN
Primary DI / UDI-DI
06970670819490
Basic UDI-DI
697067081120JX
EMDN Code
T02010101 Incision drapes, without antibacterial agent
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000026217
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Shandong Fengao Medical Technology Co., Ltd.

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Properties

  • Sterile

Other properties (12)

  • 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