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Spinamic®
EUDAMEDClass I (EU MDR)
Ref 11-4600-4Model VSP-B11-00G, VSP-B11-01G, VSP-B11-02G, VSP-B11-03G, VSP-B11-04G, VSP-B11-05G, VSP-B11-06G, VSP-B11-07G, VSP-B11-08G, VSP-B11-09G
Identity
- Device Name
- Spinamic® EUDAMED
- Model / Reference
- VSP-B11-00G, VSP-B11-01G, VSP-B11-02G, VSP-B11-03G, VSP-B11-04G, VSP-B11-05G, VSP-B11-06G, VSP-B11-07G, VSP-B11-08G, VSP-B11-09G EUDAMED11-4600-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809766910187 EUDAMED
- Basic UDI-DI
- 88097669VSPB119S EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL SPINE ORTHOSES 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
Spinamic® by VALUE & TRUST Co., 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 | 88097669VSPB119S | Class I | Active |
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Manufacturer
- Manufacturer
- VALUE & TRUST Co., Ltd.
- EUDAMED SRN
- KR-MF-000026538
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED a6934b8f-ce92-4680-a706-b63020a630b0 61 fields · synced Jun 18, 2026