Identity
- Device Name
- ROTOLI PIATTI EUDAMED
- Model / Reference
- CS008Z01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E309CS008Z010 EUDAMED
- Basic UDI-DI
- ++E309CS003Z01BW EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Rotoli Piatti by Tecno-Gaz S.p.A — 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 | ++E309CS003Z01BW | Class I | Active |
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Manufacturer
- Manufacturer
- Tecno-Gaz S.p.A
- EUDAMED SRN
- IT-MF-000010075
Sources (1)
- EUDAMED d0f83564-38b6-4628-8129-7d4527ed9d92 61 fields · synced Jun 18, 2026