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COOLPRENE Elbow Support

EUDAMED

Class I (EU MDR)

Ref 759CN-BL-FRef 759CN-BK-FRef 701CN-BK-MRef 701CN-BL-MRef 701CN-BK-L

by La Pointique Int´l Ltd.

Identity

Trade Name
COOLPRENE Elbow Support EUDAMED
Device Name
UPPER EXTREMITY ORTHOSES EUDAMED
Model / Reference
759CN-BL-F EUDAMED
759CN-BK-F EUDAMED
701CN-BK-M EUDAMED
701CN-BL-M EUDAMED
701CN-BK-L EUDAMED

Identifiers

Primary DI / UDI-DI
00840269504457 EUDAMED
00840269506918 EUDAMED
00840269524080 EUDAMED
00840269524820 EUDAMED
00840269524097 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

COOLPRENE Elbow Support 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 c4071868-c374-40e2-875d-ade25059fa13 61 fields · synced Aug 3, 2026
  • EUDAMED 8e39429f-2969-458a-a837-2d132107a60e 61 fields · synced May 17, 2026
  • EUDAMED 4007decd-e02e-472b-9b62-b45253002b15 61 fields · synced May 18, 2026
  • EUDAMED 8fe8e0d3-0684-4c2a-9281-cfda24d82bd4 61 fields · synced May 18, 2026
  • EUDAMED 67ba2d0a-ae23-470b-93b6-a05c5134ad45 61 fields · synced May 19, 2026