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SIMPLE Knee Brace K10

by Simple Medical (Shenzhen) Limited China EUDAMED

Ref 11033-LModel 11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL),11007&11011&11014&11059,11005&11006(S/M/L/XL/XXL),11017 (S/L)), EMDN Y061209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697124454KneeOrthosesED Basic UDI-DIDate8 May 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  • Withdrawn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 25 Oct 2026

Model / Reference
11003&11004&11012&11013&11016&11018&11019&11022&11049&11050(S/M/L/XL), 11007&11011&11014&11059, 11005&11006(S/M/L/XL/XXL), 11017 (S/L)), 11033-L
Primary DI / UDI-DI
06971244545531
Basic UDI-DI
697124454KneeOrthosesED
Direct Marketing DI
06971244545531
EMDN Code
Y061209 Knee 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 06971244545531|697124454KNEEORTHOSESED 61 fields · synced 25 Oct 2026