Identity
- Trade Name
- Pack PTJ SCM EUDAMED
- Device Name
- Pack EUDAMED
- Model / Reference
- 11025003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600320082950 EUDAMED
- Basic UDI-DI
- 560032008PPIIB2Y EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Conjunto de componentes de uso único, que se designam a ser utilizados durante procedimentos cirúrgicos, de forma a minimizar e prevenir o risco de infeções. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Pack PTJ SCM by Oasipor - Medical, S.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 560032008PPIIB2Y | Class IIb | Active |
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Manufacturer
- Manufacturer
- Oasipor - Medical, S.A
- EUDAMED SRN
- PT-PR-000045402
Sources (1)
- EUDAMED 289b53d0-4785-4820-8431-c231d2586a2e 61 fields · synced Jun 19, 2026