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Winged Infusion Set with/without safety features
EUDAMEDClass IIa (EU MDR)
Ref 13516Model Safety Winged Infusion set
Identity
- Trade Name
- Winged Infusion Set with/without safety features EUDAMED
- Device Name
- Winged Infusion Set with/without safety EUDAMED
- Model / Reference
- Safety Winged Infusion set EUDAMED13516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095135167 EUDAMED
- Basic UDI-DI
- 890209513511EH EUDAMED
- EMDN Code
- A01010202 BUTTERFLY NEEDLES, W/O 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
Winged Infusion Set with/without safety features by Poly Medicure Limited — Class IIa — 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 | 890209513511EH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043009
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c9c7af37-3a53-4bcd-b34d-70afe3d5f34c 61 fields · synced Jun 18, 2026