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COOLPRENE X Ankle Sleeve with Open Heel

EUDAMED

Class I (EU MDR)

Ref FT15CA-BK-LRef 704CAR1-BK-LRef 704CAR1-BK-MRef FT15CA-BK-S

by La Pointique Int´l Ltd.

Identity

Trade Name
COOLPRENE X Ankle Sleeve with Open Heel EUDAMED
Device Name
LOWER EXTREMITY ORTHOSES EUDAMED
Model / Reference
FT15CA-BK-L EUDAMED
704CAR1-BK-L EUDAMED
704CAR1-BK-M EUDAMED
FT15CA-BK-S EUDAMED

Identifiers

Primary DI / UDI-DI
00840269507519 EUDAMED
00840269505447 EUDAMED
00840269505430 EUDAMED
00840269507502 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 Ankle Sleeve with Open Heel 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 (4)

  • EUDAMED 8c331d05-e310-43c5-a3fa-5a3aa89fe008 61 fields · synced Jul 31, 2026
  • EUDAMED 7e382814-53a0-4e6f-89e9-c54907604acb 61 fields · synced May 18, 2026
  • EUDAMED 9f23228d-98de-4d01-adf7-580bc4989686 61 fields · synced May 18, 2026
  • EUDAMED b44ea619-85a2-47ae-a9e4-dfbcc84d9ddf 61 fields · synced May 18, 2026