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XSpine - Universal Spinal Brace - Adult
EUDAMEDClass I (EU MDR)
Ref XSPINEModel X-SPINE
by Chaneco Ltd
Identity
- Trade Name
- XSpine - Universal Spinal Brace - Adult EUDAMED
- Device Name
- X-Spine - Universal Spinal Brace EUDAMED
- Model / Reference
- X-SPINE EUDAMEDXSPINE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056157610499 EUDAMED
- Basic UDI-DI
- 50561576XSpineBA EUDAMED
- EMDN Code
- Y060306 THORACOLUMBAR ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
XSpine - Universal Spinal Brace - Adult by Chaneco 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 | 50561576XSpineBA | Class I | Active |
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Manufacturer
- Manufacturer
- Chaneco Ltd
- EUDAMED SRN
- UK-MF-000043937
- Authorised Representative
- UKALIA Limited XI-AR-000024526
Sources (1)
- EUDAMED c82bcd4b-4d29-4b1a-b40f-b301c6110669 61 fields · synced Jun 19, 2026