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Texton Shirt
EUDAMEDClass I (EU MDR)
Ref X-1400-002Ref X-1450-003Ref X-1450-002Ref X-1400-003Ref X-1400-004
Identity
- Trade Name
- TEXTON SHIRT EUDAMEDTEXTON SHIRT S/M M EUDAMED
- Device Name
- TEXTON SHIRT S EUDAMEDTEXTON SHIRT EUDAMEDTEXTON SHIRT S/M S EUDAMEDTEXTON SHIRT M EUDAMEDTEXTON SHIRT G EUDAMED
- Model / Reference
- X-1400-002 EUDAMEDX-1450-003 EUDAMEDX-1450-002 EUDAMEDX-1400-003 EUDAMEDX-1400-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184140022 EUDAMED08431184145034 EUDAMED08431184145027 EUDAMED08431184140039 EUDAMED08431184140046 EUDAMED
- Basic UDI-DI
- 8431184X14000022H EUDAMED8431184X145000033E EUDAMED8431184X145000248 EUDAMED8431184X14000032K EUDAMED8431184X14000042M EUDAMED
- EMDN Code
- Y060399 SPINE ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Texton Shirt by Ortoiberica S.L. — 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 | 8431184X14000022H | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (5)
- EUDAMED 21eefd4e-fc5f-451e-aec4-26c7dc84d819 61 fields · synced Jul 30, 2026
- EUDAMED 279e1743-ca3d-4fb9-a3b0-fe3440540412 61 fields · synced May 17, 2026
- EUDAMED 7d9e5110-09ec-4724-b1d9-aa70faf485cf 61 fields · synced May 18, 2026
- EUDAMED 0978b49d-9dd5-4693-a79d-0bdd7d2d1527 61 fields · synced May 19, 2026
- EUDAMED ebe837e6-95af-42e5-9505-c3870df227e0 61 fields · synced May 19, 2026