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WellKnit Silicone Back Support

EUDAMED

Class I (EU MDR)

Ref 234001(XL/UNI/Black)Model Abdominal Binder:230001 Elastic Lumbar Support:231201 Lumbar Stabilizer:231206 Lumbar Support:231205 Lumbar Support With Stays:231202 Lumbar Support With Stays:238001 Lumbofit Panel Brace:231303 Lumbofit Support:231302 etc

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
WellKnit Silicone Back Support EUDAMED
Device Name
Back Brace (Waist Support) EUDAMED
Model / Reference
Abdominal Binder:230001 Elastic Lumbar Support:231201 Lumbar Stabilizer:231206 Lumbar Support:231205 Lumbar Support With Stays:231202 Lumbar Support With Stays:238001 Lumbofit Panel Brace:231303 Lumbofit Support:231302 etc EUDAMED
234001(XL/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719892932622 EUDAMED
Basic UDI-DI
47198728623WC EUDAMED
EMDN Code
Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Ireland 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

WellKnit Silicone Back 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 e20d4d2f-af3f-4c61-b648-987adc2b16ec 61 fields · synced Oct 6, 2026