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Target Compression Ankle Sleeve
EUDAMEDClass I (EU MDR)
Ref 116XT-DB-MRef 116XT-PK-SRef 116XT-YW-SRef 116XT-YW-LRef 116XT-YW-MRef 116XT-YW-XLRef 116XT-DB-LRef 116XT-PK-LRef 116XT-BK-XLRef 116XT-BK-MRef 116XT-PK-M
Identity
- Trade Name
- Target Compression Ankle Sleeve EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 116XT-DB-M EUDAMED116XT-PK-S EUDAMED116XT-YW-S EUDAMED116XT-YW-L EUDAMED116XT-YW-M EUDAMED116XT-YW-XL EUDAMED116XT-DB-L EUDAMED116XT-PK-L EUDAMED116XT-BK-XL EUDAMED116XT-BK-M EUDAMED116XT-PK-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269540233 EUDAMED00840269540264 EUDAMED00840269540301 EUDAMED00840269540325 EUDAMED00840269540318 EUDAMED00840269540332 EUDAMED00840269540240 EUDAMED00840269540288 EUDAMED00840269540219 EUDAMED00840269540196 EUDAMED00840269540271 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
Target Compression Ankle 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 (11)
- EUDAMED f9a8c490-967e-48c1-9541-b7dab3a0b8ea 61 fields · synced Aug 2, 2026
- EUDAMED 8ed52a2b-4b55-428d-9ddf-25bb9d3becda 61 fields · synced May 17, 2026
- EUDAMED 08ff61c0-1b41-4df4-b4cc-0018102c9459 61 fields · synced May 17, 2026
- EUDAMED 025166ff-5d40-4712-91be-6f42e7effd63 61 fields · synced May 18, 2026
- EUDAMED 79611726-96d5-4784-bd2a-6cb5372730ba 61 fields · synced May 18, 2026
- EUDAMED 6e774c0d-553f-48cb-b235-58f7ba6ca12a 61 fields · synced May 18, 2026
- EUDAMED 2ef166b0-e381-46bc-808e-cc3f9f2e9f01 61 fields · synced May 18, 2026
- EUDAMED cbceffca-a4c4-44dd-8fec-8e3d6656e749 61 fields · synced May 18, 2026
- EUDAMED d1025fd8-088c-4489-86c8-f083b6b0909b 61 fields · synced May 18, 2026
- EUDAMED 66da93b1-c9a9-4b41-9b3d-08c469c547b2 61 fields · synced May 18, 2026
- EUDAMED 49420ee1-19d1-4ce2-897b-53961b54d39b 61 fields · synced May 18, 2026