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OA Knee Brace

EUDAMED

Class I (EU MDR)

Ref 525002(Universal/Left/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 525002(Universal/Right/Gray&Silver)

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
OA Knee Brace EUDAMED
Device Name
Functional Knee Brace, Knee Brace, OA Knee Brace, Post-OP Brace (Knee support orthosis) EUDAMED
Model / Reference
Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002 EUDAMED
525002(Universal/Left/Gray&Silver) EUDAMED
525002(Universal/Right/Gray&Silver) EUDAMED

Identifiers

Primary DI / UDI-DI
04719964464723 EUDAMED
04719964464730 EUDAMED
Basic UDI-DI
47199644652WH EUDAMED
EMDN Code
Y061209 KNEE ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

OA Knee Brace by Orthotech Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Orthotech Rehabilitation Co., Ltd.
EUDAMED SRN
CN-MF-000051924
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED c55f6f48-f4c8-4552-9d98-de7b3303a6ed 61 fields · synced Oct 6, 2026
  • EUDAMED 9c5229e7-df3e-4c4e-9133-e4a03f662a47 61 fields · synced May 19, 2026