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Infusion Sets
EUDAMEDClass IIa (EU MDR)
Ref 14095Model Infusion Sets with flow regulator
Identity
- Trade Name
- Infusion Sets EUDAMED
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- Infusion Sets with flow regulator EUDAMED14095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095140956 EUDAMED
- Basic UDI-DI
- 890209514091EP EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR 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
Infusion Sets 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 | 890209514091EP | 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 ca1eb63d-fa56-4b55-9322-58a332cd2b03 61 fields · synced Jun 11, 2026