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DOMINATE K95 X Knit MG Leg Sleeve
EUDAMEDClass I (EU MDR)
Ref G-K95XT-DB-LRef G-K95XT-DB-MRef G-K95XT-DB-XLRef G-K95XT-DB-S
Identity
- Trade Name
- DOMINATE K95 X Knit MG Leg Sleeve EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- G-K95XT-DB-L EUDAMEDG-K95XT-DB-M EUDAMEDG-K95XT-DB-XL EUDAMEDG-K95XT-DB-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269507229 EUDAMED00840269506789 EUDAMED00840269507236 EUDAMED00840269507212 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
DOMINATE K95 X Knit MG Leg 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08402695CL1028E | Class I | Active |
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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 dff3f862-c253-4ecd-acfd-30ebf5950b98 61 fields · synced Jul 20, 2026
- EUDAMED 8f4633cc-6f81-495a-b3c9-10c6f550d818 61 fields · synced May 17, 2026
- EUDAMED 05696546-a321-4fa7-a56f-97886e79ee8b 61 fields · synced May 17, 2026
- EUDAMED 85741218-ecc9-4cb6-83bf-55a02554de19 61 fields · synced May 18, 2026