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Elastomeric Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref 14473Model Elastomeric Infusion Pump
Identity
- Trade Name
- Elastomeric Infusion Pump EUDAMED
- Device Name
- Elastomeric Infusion Pump EUDAMED
- Model / Reference
- Elastomeric Infusion Pump EUDAMED14473 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095144732 EUDAMED
- Basic UDI-DI
- 890209514451EX EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb 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
Elastomeric Infusion Pump by Poly Medicure Limited — Class IIb — 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 | 890209514451EX | Class IIb | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 5d0f05b2-b2a8-4cf2-97db-4dd6a559d689 61 fields · synced Aug 1, 2026