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Jewett Hyperextension Brace

EUDAMED

Class I (EU MDR)

Ref 240006(S/UNI/Gray&Silver)Ref 240002(L/UNI/White)Ref 240002(XL/UNI/White)Ref 240006(L/UNI/Gray&Silver)

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
Jewett Hyperextension Brace EUDAMED
Device Name
Back Brace (Thoracolumbar Support) EUDAMED
Model / Reference
240006(S/UNI/Gray&Silver) EUDAMED
240002(L/UNI/White) EUDAMED
240002(XL/UNI/White) EUDAMED
240006(L/UNI/Gray&Silver) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872869269 EUDAMED
04719872861836 EUDAMED
04719872861867 EUDAMED
04719872869283 EUDAMED
Basic UDI-DI
47198728624WE EUDAMED
EMDN Code
Y060306 THORACOLUMBAR 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

Jewett Hyperextension Brace 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

EUDAMED SRN
CN-MF-000011447
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (4)

  • EUDAMED 8f75f3cf-7d09-4160-8703-19b0dc1de976 61 fields · synced Oct 8, 2026
  • EUDAMED f6b5e431-f148-480f-9625-be4c3055d348 61 fields · synced May 17, 2026
  • EUDAMED ed0db15d-ecec-4ed3-ba3f-66ddae7271df 61 fields · synced May 19, 2026
  • EUDAMED 7fa0d53b-a95f-43fa-855e-b60981f9982c 61 fields · synced May 19, 2026