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Wrist Brace

EUDAMED

Class I (EU MDR)

Ref 552-L-BK-XLRef 552-L-BK-LRef 552-R-BK-XLRef 552-R-BK-SRef 552-R-BK-L

by La Pointique Int´l Ltd.

Identity

Trade Name
Wrist Brace EUDAMED
Device Name
UPPER EXTREMITY ORTHOSES EUDAMED
Model / Reference
552-L-BK-XL EUDAMED
552-L-BK-L EUDAMED
552-R-BK-XL EUDAMED
552-R-BK-S EUDAMED
552-R-BK-L EUDAMED

Identifiers

Primary DI / UDI-DI
00840269510922 EUDAMED
00840269510908 EUDAMED
00840269510915 EUDAMED
00840269510854 EUDAMED
00840269510892 EUDAMED
Basic UDI-DI
08402695CL1038G EUDAMED
EMDN Code
Y060699 ORTHOSES, UPPER EXTREMITY - OTHER 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

Wrist Brace by La Pointique Int´l 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
US-MF-000005204
Authorised Representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (5)

  • EUDAMED c5d56f08-f4f2-48e1-8228-530cbd997190 61 fields · synced Jul 26, 2026
  • EUDAMED 10f89e1a-1551-4a72-baea-e693f68e1cb3 61 fields · synced May 17, 2026
  • EUDAMED 073cb491-0cce-4b40-8eac-3e37c03c3f78 61 fields · synced May 18, 2026
  • EUDAMED 88c447be-1a05-49ad-a994-e1b5ca7dac2d 61 fields · synced May 18, 2026
  • EUDAMED 8a015bf9-b5b3-459d-8806-41c5e75716e3 61 fields · synced May 18, 2026