Identity
- Trade Name
- COSMETICA PLASTAZOTE B/K T/L EUDAMED
- Device Name
- COSMETICA TIBIAL EUDAMED
- Model / Reference
- P-0064-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184006434 EUDAMED
- Basic UDI-DI
- 8431184P006VN EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND 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
Cosmetica Plastazote B/K T/L 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 | 8431184P006VN | Class I | Active |
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Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (1)
- EUDAMED 978aef77-8e7b-418c-a151-56897333c08c 61 fields · synced Jul 9, 2026