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X KNIT Back Support with Extra Lumbar Support and BILATERAL COMPRESSIVE STRAPS
EUDAMEDClass I (EU MDR)
Ref SP61XT-DB-LRef SP61XT-DB-XXL-1Ref SP61XT-DB-MRef SP61XT-DB-XLRef SP61XT-DB-XL-1Ref SP61XT-DB-M-1Ref SP61XT-DB-S
Identity
- Trade Name
- X KNIT Back Support with Extra Lumbar Support and BILATERAL COMPRESSIVE STRAPS EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- SP61XT-DB-L EUDAMEDSP61XT-DB-XXL-1 EUDAMEDSP61XT-DB-M EUDAMEDSP61XT-DB-XL EUDAMEDSP61XT-DB-XL-1 EUDAMEDSP61XT-DB-M-1 EUDAMEDSP61XT-DB-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269507441 EUDAMED04719890077226 EUDAMED00840269506871 EUDAMED00840269507458 EUDAMED04719890077219 EUDAMED04719890077196 EUDAMED00840269507434 EUDAMED
- Basic UDI-DI
- 08402695CL1048J EUDAMED471988489CL104GN EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDMalta 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
X KNIT Back Support with Extra Lumbar Support and BILATERAL COMPRESSIVE STRAPS by La Pointique Int´l Ltd. — Class I — MDR — listed in EUDAMED
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 | 08402695CL1048J | 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 (7)
- EUDAMED 030a5926-8514-4d57-8eef-3b7832ca3296 61 fields · synced Aug 3, 2026
- EUDAMED 52f0234f-8c6e-4ec2-8f04-f04b531c81fe 61 fields · synced May 17, 2026
- EUDAMED cb77aca5-802f-4e88-9d50-7ec36f2b923f 61 fields · synced May 17, 2026
- EUDAMED 2f580011-a99f-48d0-b84e-f438aebc69bd 61 fields · synced May 17, 2026
- EUDAMED db9c5699-6b5a-489a-a2e0-5ad624a59f10 61 fields · synced May 17, 2026
- EUDAMED 9300784e-99a3-4cf0-82a8-4b0920937806 61 fields · synced May 18, 2026
- EUDAMED 0b9280d9-b8b2-41a0-9a3d-f3d4a8772912 61 fields · synced May 18, 2026