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Fcare

by Jiangsu Jiele Medical Dressing Co., Ltd China EUDAMED

Ref 05.28651962

EMDN M0201020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697506955gauzespongesKC Basic UDI-DIDate23 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Gauze sponges
Model / Reference
05.28651962
Primary DI / UDI-DI
06975069551647
Basic UDI-DI
697506955gauzespongesKC
EMDN Code
M0201020201 Cotton gauzes, folded, with x-ray detectable thread, sterile
Device Class
Class I
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000008773
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Jiele Medical Dressing Co., Ltd

See all devices from Jiangsu Jiele Medical Dressing Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED a3c63c5d-bcbb-4e65-a7bb-6826741c74ef 61 fields · synced 23 Oct 2026