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IV Administration Set
EUDAMEDClass IIa (EU MDR)
Ref 14370Model Infusion set with airventRef PT+PU400WY (14370)Model Infusion Set with/without airvent
Identity
- Trade Name
- IV Administration Set EUDAMED
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- Infusion set with airvent EUDAMED14370 EUDAMEDInfusion Set with/without airvent EUDAMEDPT+PU400WY (14370) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095143704 EUDAMED
- Basic UDI-DI
- 890209514002DW EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
IV Administration Set 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 | 890209514002DW | 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 (2)
- EUDAMED 120e3664-c7ff-400a-9faf-03c197a6f844 61 fields · synced Jun 18, 2026
- EUDAMED 6b289878-f6cb-464c-9a2b-bde78376a042 61 fields · synced Jun 11, 2026