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Infusion Sets with flow regulator
EUDAMEDClass IIa (EU MDR)
Ref 14103Model Infusion Sets with flow regulator
Identity
- Trade Name
- Infusion Sets with flow regulator EUDAMED
- Device Name
- Infusion Sets EUDAMED
- Model / Reference
- Infusion Sets with flow regulator EUDAMED14103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095141038 EUDAMED
- Basic UDI-DI
- 890209514092ER EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR 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 flow regulator 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 | 890209514092ER | 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 26846d68-465e-464d-a97b-68a1df1601eb 61 fields · synced Jun 18, 2026