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Back Support 1.0
EUDAMEDClass I (EU MDR)
Ref 160XT-BK-XLRef 160XT-BK-SRef 160XT-BK-MRef 160XT-BK-L
Identity
- Trade Name
- Back Support 1.0 EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 160XT-BK-XL EUDAMED160XT-BK-S EUDAMED160XT-BK-M EUDAMED160XT-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269505157 EUDAMED00840269505126 EUDAMED00840269505133 EUDAMED00840269505140 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 1.0 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 (4)
- EUDAMED a8f9d7af-8064-49d9-bda5-e5d81496dad4 61 fields · synced Sep 18, 2026
- EUDAMED 7832c3c4-cc2a-4261-beda-63f9136b19c2 61 fields · synced May 17, 2026
- EUDAMED 129e342d-9958-49b4-8d78-e98b58029629 61 fields · synced May 17, 2026
- EUDAMED 6a8ff0e6-4b58-4f4c-978e-2902d8763b1d 61 fields · synced May 18, 2026