← Back to catalogue
SafeR Sting
EUDAMEDClass IIa (EU MDR)
Ref SFN2125Model SFN2038Ref SFN2032Ref SFN2525Ref SFN2325Ref SFN2238Ref SFN2225Ref SFN2625Ref SFN2232Ref SFN2025Ref SFN2338Ref SFN2138
Identity
- Trade Name
- SafeR Sting EUDAMED
- Device Name
- SafeR Sting EUDAMED
- Model / Reference
- SFN2038 EUDAMEDSFN2125 EUDAMEDSFN2032 EUDAMEDSFN2525 EUDAMEDSFN2325 EUDAMEDSFN2238 EUDAMEDSFN2225 EUDAMEDSFN2625 EUDAMEDSFN2232 EUDAMEDSFN2025 EUDAMEDSFN2338 EUDAMEDSFN2138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056999020118 EUDAMED08056999020071 EUDAMED08056999020187 EUDAMED08056999020170 EUDAMED08056999020125 EUDAMED08056999020149 EUDAMED08056999020200 EUDAMED08056999020132 EUDAMED08056999020088 EUDAMED08056999020156 EUDAMED08056999020095 EUDAMED
- Basic UDI-DI
- 805699902StingCP002000177 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Hypodermic needle, single-use
SafeR Sting by Roncadelle Operations Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
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 | 805699902StingCP002000177 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roncadelle Operations Srl
- EUDAMED SRN
- IT-MF-000017979
Sources (11)
- EUDAMED 3088452e-31aa-4f22-8d4f-7f51164ea9ee 61 fields · synced Aug 2, 2026
- EUDAMED f789ea96-ebce-42c9-bd3c-59d550a7430f 61 fields · synced May 16, 2026
- EUDAMED cd9aed29-8141-469a-8830-102357ca44d5 61 fields · synced May 16, 2026
- EUDAMED 4f0f7550-5187-4725-a63a-33ed7f66328c 61 fields · synced May 17, 2026
- EUDAMED 730dcc48-422a-4808-aa2d-f618aff4936a 61 fields · synced May 17, 2026
- EUDAMED 85a25307-be18-4508-9726-8183fb47b5f8 61 fields · synced May 17, 2026
- EUDAMED 3019a920-30f6-4d3e-a4c6-3f78a6cab3ac 61 fields · synced May 17, 2026
- EUDAMED d0048e91-8bbd-4797-a5ab-a1b522476b4a 61 fields · synced May 17, 2026
- EUDAMED 0a5ab1a9-4e45-45a5-a81a-92c181c06dd1 61 fields · synced May 18, 2026
- EUDAMED 1f73a0b2-9f30-4b25-88c5-0c29f940ad49 61 fields · synced Jul 8, 2026
- EUDAMED f27ee8c6-dcfe-4442-b03c-75959c578e0a 61 fields · synced Jul 9, 2026