Identity
- Trade Name
- SafeR Syringe EUDAMED
- Device Name
- SafeR Syringe EUDAMED
- Model / Reference
- SFS0100 EUDAMEDSFS0500 EUDAMEDSFS0200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056999020040 EUDAMED08056999020002 EUDAMED08056999020019 EUDAMED
- Basic UDI-DI
- 805699902SyringeCP00201F9 EUDAMED
- EMDN Code
- A02010205 INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SafeR Syringe by Roncadelle Operations Srl — 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 | 805699902SyringeCP00201F9 | Class I | Active |
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Manufacturer
- Manufacturer
- Roncadelle Operations Srl
- EUDAMED SRN
- IT-MF-000017979
Sources (3)
- EUDAMED 7d6f267d-e917-4f26-96d9-0ac10e1f80f1 61 fields · synced Jul 30, 2026
- EUDAMED 3117b2ca-b0dc-467e-90f4-5a198f194fe8 61 fields · synced May 16, 2026
- EUDAMED e6ffaa3d-d06a-4bf2-be43-a66d2bf6189b 61 fields · synced May 17, 2026