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Winged Infusion Set with/without safety features
EUDAMEDClass IIa (EU MDR)
Ref 13401Model Safety Winged Infusion setRef 13409Ref 13403Ref 13404Ref 13405Ref 13408Ref 135178902095135174Ref 13526Ref 13512Ref 13525Ref 13511Ref 13524Ref 13513Ref 13523Ref 13514Ref 13522Ref 13518Ref 13521
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 EUDAMED13401 EUDAMED13409 EUDAMED13403 EUDAMED13404 EUDAMED13405 EUDAMED13408 EUDAMED135178902095135174 EUDAMED13526 EUDAMED13512 EUDAMED13525 EUDAMED13511 EUDAMED13524 EUDAMED13513 EUDAMED13523 EUDAMED13514 EUDAMED13522 EUDAMED13518 EUDAMED13521 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095134016 EUDAMED08902095134092 EUDAMED08902095134030 EUDAMED08902095134047 EUDAMED08902095134054 EUDAMED08902095134085 EUDAMED08902095135174 EUDAMED08902095135266 EUDAMED08902095135129 EUDAMED08902095135259 EUDAMED08902095135112 EUDAMED08902095135242 EUDAMED08902095135136 EUDAMED08902095135235 EUDAMED08902095135143 EUDAMED08902095135228 EUDAMED08902095135181 EUDAMED08902095135211 EUDAMED
- Basic UDI-DI
- 890209513511EH EUDAMED
- EMDN Code
- A01010201 BUTTERFLY NEEDLES, WITH SAFETY SYSTEMS EUDAMEDA01010202 BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDItaly 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 (18)
- EUDAMED cba0ae9c-28cb-4a78-9c9c-f038372e7bf8 61 fields · synced Aug 3, 2026
- EUDAMED d34199e2-0bd2-4106-b2b9-ac0288e155f7 61 fields · synced May 17, 2026
- EUDAMED 29b65fed-d2d9-4701-80e0-9b49f90c8c8e 61 fields · synced May 18, 2026
- EUDAMED f2665e9a-2fd3-4b25-ad00-069f129784e1 61 fields · synced May 18, 2026
- EUDAMED ed69c563-4b18-4111-b641-2344fb6a4962 61 fields · synced May 18, 2026
- EUDAMED d2d8aa41-ac9a-4e97-9949-611ff7e477da 61 fields · synced May 18, 2026
- EUDAMED dcf86ca3-9899-48b5-851a-7ad075b003da 61 fields · synced Jun 20, 2026
- EUDAMED a734fc4f-d435-4f8d-9fcd-069690d2e40d 61 fields · synced Jul 9, 2026
- EUDAMED afa259ea-2f44-4d60-8b74-0296e0c4ba7f 61 fields · synced Jul 10, 2026
- EUDAMED cc521338-06a4-46b6-88e2-9b0a501de741 61 fields · synced Jul 11, 2026
- EUDAMED cfb46e49-5f4f-4770-a0a7-8a0fd0f1910c 61 fields · synced Jul 15, 2026
- EUDAMED d4a350f2-fae4-426f-b4e2-8c56d9aadfc9 61 fields · synced Jul 16, 2026
- EUDAMED 446aa31c-695f-4d99-8654-8787c63d1255 61 fields · synced Jul 17, 2026
- EUDAMED 4f0a3347-118e-46fe-b8ba-c9acd3b9f9af 61 fields · synced Jul 23, 2026
- EUDAMED 7c2e1dbd-82c7-49fb-a351-28f633e45671 61 fields · synced Jul 25, 2026
- EUDAMED bccab121-0b8a-40d9-9844-f9a2e834fb0e 61 fields · synced Jul 28, 2026
- EUDAMED 2e1e44f0-b68d-44cc-b501-a1ff956038af 61 fields · synced Jul 28, 2026
- EUDAMED 67d0b10a-a960-4651-81d7-71632628f903 61 fields · synced Aug 3, 2026