Identity
- Trade Name
- 3 TELO POLI-SAFE 100X140 EUDAMED
- Device Name
- KIT TTR EUDAMED
- Model / Reference
- TRxxx(y) EUDAMEDTR1002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056711841830 EUDAMED
- Basic UDI-DI
- 805671184TTRTR014C EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Kit sterili per procedure cliniche in tessuto tecnico riutilizzabile (TTR) - Sterile clinical procedures kits in reusable technical fabrics EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
3 Telo Poli-Safe 100x140 by Linea Sterile S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 805671184TTRTR014C | Class I | Active |
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Manufacturer
- Manufacturer
- LINEA STERILE S.p.A.
- EUDAMED SRN
- IT-PR-000033798
Sources (1)
- EUDAMED 7b83c6a8-06a2-494e-a948-622cd11d1fc9 61 fields · synced Jul 26, 2026