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Gauze Sponges

by Shanghai Sunshore Medical Instruments Co., Ltd EUDAMED

Active European Union

Ref 5x5cm-4plyModel 5x5cm-4ply,8ply,12ply,16ply;7.5x7.5cm-4ply, 8ply,12ply,16ply; 10x10cm-4ply, 8ply,12ply,16ply;10x20cm-4ply, 8ply,12ply,16ply; 1/4yardsx1yards-4ply, 8ply,12ply,16ply;1/2yardsx1yards-4ply, 8ply,12ply,16ply; 1yardsx1yards-4ply, 8ply,12ply,16ply; etc.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698023123GS0017E Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Gauze Sponges
Model / Reference
5x5cm-4ply, 8ply, 12ply, 16ply, 7.5x7.5cm-4ply, 10x10cm-4ply, 10x20cm-4ply, 1/4yardsx1yards-4ply, 1/2yardsx1yards-4ply, 1yardsx1yards-4ply, etc.
Primary DI / UDI-DI
06980231230749
Basic UDI-DI
698023123GS0017E
EMDN Code
M020199 Cotton gauzes - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000056183
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Sunshore Medical Instruments Co., Ltd

See all devices from Shanghai Sunshore Medical Instruments 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