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Coolprene Thigh Sleeve

EUDAMED

Class I (EU MDR)

Ref 705CN-BL-XLRef 705CN-BK-LRef 705CN-BK-SRef 705CN-BK-XLRef 705CN-BL-L

by La Pointique Int´l Ltd.

Identity

Trade Name
COOLPRENE THIGH SLEEVE EUDAMED
Device Name
LOWER EXTREMITY ORTHOSES EUDAMED
Model / Reference
705CN-BL-XL EUDAMED
705CN-BK-L EUDAMED
705CN-BK-S EUDAMED
705CN-BK-XL EUDAMED
705CN-BL-L EUDAMED

Identifiers

Primary DI / UDI-DI
00840269525926 EUDAMED
00840269525872 EUDAMED
00840269525858 EUDAMED
00840269525889 EUDAMED
00840269525919 EUDAMED
Basic UDI-DI
08402695CL1028E EUDAMED
EMDN Code
Y061299 LOWER EXTREMITY ORTHOSES - 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 Thigh Sleeve 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 ff03c5c1-c116-4234-b9b0-1774d96f236c 61 fields · synced Sep 18, 2026
  • EUDAMED 4f5093ee-7336-48db-9210-e7e36028ce50 61 fields · synced May 17, 2026
  • EUDAMED 21f6fbe8-538e-4ba2-b4cf-277bdc01773c 61 fields · synced May 17, 2026
  • EUDAMED af4ccd80-6d72-4483-98e4-1c3065a290d9 61 fields · synced May 18, 2026
  • EUDAMED 0a911de4-160e-4ac6-b8a6-838be58b63c3 61 fields · synced May 19, 2026