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Infusion Sets with/ without airvent
EUDAMEDClass IIa (EU MDR)
Ref 14190Model Infusion Sets with/ without airvent
Identity
- Trade Name
- Infusion Sets with/ without airvent EUDAMED
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- Infusion Sets with/ without airvent EUDAMED14190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095141908 EUDAMED
- Basic UDI-DI
- 890209514005E4 EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infusion Sets with/ without airvent 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 | 890209514005E4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000042557
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 6beb692c-66be-4ff8-8ada-462f99e0f643 61 fields · synced Jul 26, 2026