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Simple 3D Ctlso-O

by Simple Medical (Shenzhen) Limited China EUDAMED

Ref D-CTLSO-O-SModel 51001,51002,51007,51301,51302,51304,51320,51325,52001,52002,52003,52006,52008,52009,52013,52024,52025,52026

EMDN Y060318

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697124454SpineOrthoses7Y Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
51001, 51002, 51007, 51301, 51302, 51304, 51320, 51325, 52001, 52002, 52003, 52006, 52008, 52009, 52013, 52024, 52025, 52026, D-CTLSO-O-S
Primary DI / UDI-DI
06971244544657
Basic UDI-DI
697124454SpineOrthoses7Y
Direct Marketing DI
06971244544657
EMDN Code
Y060318 Cervicothoracolumbosacral spine orthoses
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000013198
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Simple Medical (Shenzhen) Limited

See all devices from Simple Medical (Shenzhen) Limited →

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 2735c145-3d59-4415-8aa3-0d14e3cd6db5 61 fields · synced 22 Oct 2026