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WellKnit Back Stabilizer

EUDAMED

Class I (EU MDR)

Ref 234002(2XL/UNI/Black)Model Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc

by Orthotech Rehabilitation Co., Ltd.

Identity

Trade Name
WellKnit Back Stabilizer EUDAMED
Device Name
Back Brace (Waist Support) EUDAMED
Model / Reference
Abdominal Binder 230001 Elastic Lumbar Support 231201 Lumbar Stabilizer 231206 Lumbar Support With Stays 231202 Lumbar Support With Stays 238001 Lumbofit Panel Brace 231303 Lumbofit Support 231302 Lumbosacral Support 231204 etc EUDAMED
234002(2XL/UNI/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719964466901 EUDAMED
Basic UDI-DI
47199644623WA 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 Back Stabilizer 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 (1)

  • EUDAMED cb751a16-7926-49f0-87ba-77e47ee1ecde 61 fields · synced Aug 2, 2026