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Post-op Knee Brace

EUDAMED

Class I (EU MDR)

Ref 521001(Universal/UNI/Black)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 OA Knee Brace:525002Ref 521003(Universal/UNI/Black)

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
Post-op 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
521001(Universal/UNI/Black) EUDAMED
521003(Universal/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892938068 EUDAMED
04719892938112 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

Post-op 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 1e05ca5f-3fcf-40f5-a138-69ea270337e6 61 fields · synced Oct 6, 2026
  • EUDAMED 3ab78fb8-ef13-48b6-be49-5b7dc6cc462a 61 fields · synced May 19, 2026