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Daily Oa Knee Brace

by Orthotech Rehabilitation Co., Ltd. China EUDAMED

Ref 525004(Universal/Left/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 DAILY OA KNEE BRACE:525004 EMDN Y061209

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47199644652WH Basic UDI-DIDate14 Apr 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  • Withdrawn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

Device Name
Functional Knee Brace, Knee Brace, OA Knee Brace, Post-OP Brace (Knee support orthosis)
Model / Reference
Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 DAILY OA KNEE BRACE:525004, 525004(Universal/Left/Black)
Primary DI / UDI-DI
04719892934251
Basic UDI-DI
47199644652WH
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000051924
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Orthotech Rehabilitation Co., Ltd.

See all devices from Orthotech Rehabilitation Co., Ltd. →

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 04719892934251|47199644652WH 61 fields · synced 25 Oct 2026