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Disposable Skin Retractors

by Surgitools（Shanghai）Medical Instruments Co., Ltd. EUDAMED

Active European Union

Ref SG1603-H-2Model SG16

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697144135SG16GX Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Device Name
Disposable Skin Retractors
Model / Reference
SG16, SG1603-H-2
Primary DI / UDI-DI
06971441350099, 06974794561921
Basic UDI-DI
697144135SG16GX, 697479456SG160X-H8X
Direct Marketing DI
06971441350099
06974794561921
EMDN Code
K01020106 Minimally invasive surgery spreaders and retractors, single-use
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000055047
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Surgitools（Shanghai）Medical Instruments Co., Ltd.

See all devices from Surgitools（Shanghai）Medical Instruments Co., Ltd. →

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