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COOLPRENE X Knee Sleeve

EUDAMED

Class I (EU MDR)

Ref FT75CA-BK-SRef 706CAR1-BK-XLRef FT75CA-BK-XLRef 706CAR1-BK-LRef 706CAR1-BK-S

by La Pointique Int´l Ltd.

Identity

Trade Name
COOLPRENE X Knee Sleeve EUDAMED
Device Name
LOWER EXTREMITY ORTHOSES EUDAMED
Model / Reference
FT75CA-BK-S EUDAMED
706CAR1-BK-XL EUDAMED
FT75CA-BK-XL EUDAMED
706CAR1-BK-L EUDAMED
706CAR1-BK-S EUDAMED

Identifiers

Primary DI / UDI-DI
00840269507472 EUDAMED
00840269505492 EUDAMED
00840269507496 EUDAMED
00840269505485 EUDAMED
00840269505461 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 X Knee 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 ba2651b6-c799-4edb-9edd-f0a731cd8d19 61 fields · synced Sep 17, 2026
  • EUDAMED 2e09a915-c2fe-49fd-afaf-3eabf9fa0719 61 fields · synced May 18, 2026
  • EUDAMED a2d525c6-18f0-423e-a847-8306805fe9a6 61 fields · synced May 18, 2026
  • EUDAMED 73814179-347e-4030-b2da-44e45b1f6e77 61 fields · synced May 19, 2026
  • EUDAMED e07034e5-b908-4181-ab87-5067f18a5277 61 fields · synced May 19, 2026