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Wrist Brace 1.0

EUDAMED

Class I (EU MDR)

Ref 130XT-BK-MRef 130XT-BK-LRef 130XT-BK-XXLRef 130XT-BK-SRef 130XT-BK-XL

by La Pointique Int´l Ltd.

Identity

Trade Name
Wrist Brace 1.0 EUDAMED
Device Name
UPPER EXTREMITY ORTHOSES EUDAMED
Model / Reference
130XT-BK-M EUDAMED
130XT-BK-L EUDAMED
130XT-BK-XXL EUDAMED
130XT-BK-S EUDAMED
130XT-BK-XL EUDAMED

Identifiers

Primary DI / UDI-DI
00840269537035 EUDAMED
00840269505058 EUDAMED
00840269505072 EUDAMED
00840269505041 EUDAMED
00840269505065 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 1.0 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

Manufacturer
La Pointique Int´l Ltd.
EUDAMED SRN
US-MF-000005204
Authorised Representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (5)

  • EUDAMED 79adf31f-796c-4d4f-a69e-7e041828194a 61 fields · synced Jul 30, 2026
  • EUDAMED 08df698c-049e-4221-82b2-554e56696f2a 61 fields · synced May 17, 2026
  • EUDAMED d6d860d8-a07b-429c-8b13-10526bdfbfff 61 fields · synced May 18, 2026
  • EUDAMED 1a33cf86-806c-4b94-89f6-ce9ffa4bf336 61 fields · synced May 18, 2026
  • EUDAMED bae95051-d0b1-49d4-aa98-96137d4fd70b 61 fields · synced May 18, 2026