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Fenestrated drape

by Xuchang Zhengde Environstar Medical Products Co., Ltd. China EUDAMED

Ref RFEO03-7611

EMDN T02010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69317478NSD00000146 Basic UDI-DIDate10 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non sterile drapes
Model / Reference
RFEO03-7611
Primary DI / UDI-DI
06931747824274
Basic UDI-DI
69317478NSD00000146
EMDN Code
T02010101 Incision drapes, without antibacterial agent
Device Class
Class I
Market of Registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000009427
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Xuchang Zhengde Environstar Medical Products Co., Ltd.

See all devices from Xuchang Zhengde Environstar Medical Products Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 05cab3fa-293e-48a9-aa6a-1cbee7a956b3 61 fields · synced 22 Oct 2026