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Disposable Skin Retractors

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

Ref SG1602-H-1Model SG16 EMDN K01020106

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  • Withdrawn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 · synced 23 Oct 2026

Device Name
Disposable Skin Retractors
Model / Reference
SG16, SG1602-H-1
Primary DI / UDI-DI
06971441351461, 06974794561884
Basic UDI-DI
697144135SG16GX, 697479456SG160X-H8X
Direct Marketing DI
06971441351461
06974794561884
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 & 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 (2)

  • EUDAMED 869e5249-9f89-47d7-b8c0-aa6efe9644d1 61 fields · synced 23 Oct 2026
  • EUDAMED 06974794561884|697479456SG160X-H8X 61 fields · synced 8 Oct 2026