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Back Support 2.0
EUDAMEDClass I (EU MDR)
Ref 161XT-BK-LRef 161XT-BK-XLRef 161XT-BK-SRef 161XT-BK-MRef 161XT-BK-XXL
Identity
- Trade Name
- Back Support 2.0 EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 161XT-BK-L EUDAMED161XT-BK-XL EUDAMED161XT-BK-S EUDAMED161XT-BK-M EUDAMED161XT-BK-XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269505195 EUDAMED00840269505201 EUDAMED00840269505171 EUDAMED00840269505188 EUDAMED00840269505218 EUDAMED
- Basic UDI-DI
- 08402695CL1048J EUDAMED
- EMDN Code
- Y060399 SPINE 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
Back Support 2.0 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 | 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 (5)
- EUDAMED 163f60ba-21ca-420d-b939-00e845f2982c 61 fields · synced Jul 25, 2026
- EUDAMED a037785f-f037-4c4a-a1ef-f7152f243c68 61 fields · synced May 17, 2026
- EUDAMED 676cdeda-a950-4990-8e08-d7cf623649fd 61 fields · synced May 17, 2026
- EUDAMED 6c051a75-5de7-46fc-b6c1-aa25e327080f 61 fields · synced May 18, 2026
- EUDAMED 8da7c9e5-e629-454f-a2af-6f8eb59cb9a5 61 fields · synced May 18, 2026