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Knee Immobilizer

by Orthotech Rehabilitation Co., Ltd. 13 variants

Ref 521004(18XL/UNI/Gray&Silver), 521004(18XXL/UNI/Gray&Silver), 521004(20XXL/UNI/Gray&Silver), 521004(16XL/UNI/Gray&Silver), 521004(22XL/UNI/Gray&Silver), 521004(18S/UNI/Gray&Silver), 521004(20M/UNI/Gray&Silver), 521004(20XL/UNI/Gray&Silver), 521004(22M/UNI/Gray&Silver), 521004(16M/UNI/Gray&Silver)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

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number47199644652WH Basic UDI-DI Date14 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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, 521004(18XL/UNI/Gray&Silver), 521004(18XXL/UNI/Gray&Silver), 521004(20XXL/UNI/Gray&Silver), 521004(16XL/UNI/Gray&Silver), 521004(22XL/UNI/Gray&Silver), 521004(18S/UNI/Gray&Silver), 521004(20M/UNI/Gray&Silver), 521004(20XL/UNI/Gray&Silver), 521004(22M/UNI/Gray&Silver), 521004(16M/UNI/Gray&Silver)
Primary DI / UDI-DI
04719892938754, 04719892938761, 04719892938815, 04719964466161, 04719892938853, 04719892938747, 04719892938785, 04719892938808, 04719892938839, 04719892938693
Basic UDI-DI
47199644652WH
EMDN Code
Y061209 Knee orthoses
Device Class
Class I
EU market of registration
Poland

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

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