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Industrial Back Support
EUDAMEDClass I (EU MDR)
Ref 912-BK-XLRef 912-BK-MRef 912-BK-SRef 912-BK-L
Identity
- Trade Name
- Industrial Back Support EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 912-BK-XL EUDAMED912-BK-M EUDAMED912-BK-S EUDAMED912-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269535710 EUDAMED00840269535697 EUDAMED00840269535680 EUDAMED00840269535703 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
Yes
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
Industrial Back Support 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 73651321-928d-4ab9-8ceb-e9bc00dee35c 61 fields · synced Jul 27, 2026
- EUDAMED fa827e6e-436c-42ee-9dbb-58b99e81f350 61 fields · synced May 18, 2026
- EUDAMED dc0b1085-4c0a-42ea-bb37-9e79a60525a8 61 fields · synced May 18, 2026
- EUDAMED 8d9bb53e-d7fc-4f71-a4ed-33cbc21e1ede 61 fields · synced May 18, 2026