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SIMPLE Post-Op Shoe BF6

by Simple Medical (Shenzhen) Limited China EUDAMED

Ref 61017-SModel 61001,61002,61003,61004,61005,61006,61015,61016,61017,62005,62007,62009,62010,62011,62012,62013,62014,62015,62034,62047

EMDN Y06120601

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697124454AnkleOrthosesEM Basic UDI-DIDate9 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
61001, 61002, 61003, 61004, 61005, 61006, 61015, 61016, 61017, 62005, 62007, 62009, 62010, 62011, 62012, 62013, 62014, 62015, 62034, 62047, 61017-S
Primary DI / UDI-DI
06971244542608
Basic UDI-DI
697124454AnkleOrthosesEM
Direct Marketing DI
06971244542608
EMDN Code
Y06120601 Passive ankle-foot 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 e5a19ebd-c5e1-4a91-ad3e-07cbbda08fc2 61 fields · synced 22 Oct 2026