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Back Support (With Stays)
EUDAMEDClass I (EU MDR)
Ref 727-TAN-XLRef 919-BK-L/XLRef 919KM-BK-L/XLRef 727-TAN-FRef 919-BK-S/M
Identity
- Trade Name
- Back Support (With Stays) EUDAMEDBack Support with Stays EUDAMED
- Device Name
- SPINE ORTHOSES EUDAMED
- Model / Reference
- 727-TAN-XL EUDAMED919-BK-L/XL EUDAMED919KM-BK-L/XL EUDAMED727-TAN-F EUDAMED919-BK-S/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269540882 EUDAMED00840269535888 EUDAMED00840269501708 EUDAMED00840269519079 EUDAMED00840269535871 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
EUDAMEDEUDAMED
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 (With Stays) 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 3503d04f-c72a-4097-9d30-e341aaa20b5d 61 fields · synced Jul 28, 2026
- EUDAMED 071827eb-4ee9-4e2e-a702-c2ff6f9090f7 61 fields · synced May 17, 2026
- EUDAMED 01e03d13-0179-4082-be43-681a2600983b 61 fields · synced May 17, 2026
- EUDAMED 22e411d9-f6d1-47d1-972e-27cc137933b7 61 fields · synced May 18, 2026
- EUDAMED 9b80a6f6-8440-4dee-ba4f-9822177c159e 61 fields · synced May 18, 2026