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Gauze Swab(Sponge)

by Shanghai Bize Import and Export Co., Ltd China EUDAMED

Ref SH-100005AModel H-100005; SH-100005A; SH-100005B; SH-100005C; SH-100005D; EMDN M020199

Overview

Our Gauze Swab(Sponge) device is a high-quality, effective medical tool used for wound care and surgical procedures. The device features a unique sponge material that provides excellent absorbency and sterileness, making it ideal for various medical applications. With its simple design and easy-to-use packaging, this device is perfect for individuals seeking reliable and efficient care.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697587603GauzeSwabA4 Basic UDI-DIDate15 Jan 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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
H-100005, SH-100005A, SH-100005B, SH-100005C, SH-100005D
Primary DI / UDI-DI
06975876037006
Basic UDI-DI
697587603GauzeSwabA4
EMDN Code
M020199 Cotton gauzes - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000037405
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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 ad81110c-ff01-4900-8d97-0e36e427e552 61 fields · synced 22 Oct 2026