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Hinged Knee Support

EUDAMED

Class I (EU MDR)

Ref 520004(XS/UNI/Gray&Silver)Model Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
Hinged Knee Support 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 Functional Knee Brace:527001 Functional Knee Brace:527002 Knee Ligament Defender:527003 PCL Revive:527005 EUDAMED
520004(XS/UNI/Gray&Silver) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872868637 EUDAMED
Basic UDI-DI
47198728652WK EUDAMED
EMDN Code
Y061209 KNEE ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Hinged Knee Support by Zhangpu Ortholife 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
Zhangpu Ortholife Rehabilitation Co., Ltd.
EUDAMED SRN
CN-MF-000011447
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED b4c9fd46-1aa8-4f56-b530-47881f531746 61 fields · synced Oct 7, 2026