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Elastomeric Infusion Pump
EUDAMEDClass IIb (EU MDR)
Ref 14477Model Elastomeric Infusion Pump
Identity
- Trade Name
- Elastomeric Infusion Pump EUDAMED
- Device Name
- Elastomeric Infusion Pump EUDAMED
- Model / Reference
- Elastomeric Infusion Pump EUDAMED14477 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095144770 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
Category: Elastomeric infusion pump system
Elastomeric Infusion Pump by Poly Medicure Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Elastomeric infusion pump system.
- SMARTeZ Plus-PainBloc-Fixed Flow 240-10-24h — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ RS-General Infusion 250-500-30m with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- Neofuser Twin — S&S Med Co.,Ltd. · Class IIb
- Halyard — Avanos Medical, Inc. · Class II
- SMARTeZ RS-PainBloc-Fixed Flow Rate 120-5-24h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
- SMARTeZ Pump 500-40-12.5h — Epic International (Thailand) Co., Ltd. · Class IIa
- Halyard — Avanos Medical, Inc. · Class II
- SMARTeZ RS-PainBloc-Fixed Flow Rate 80-5-16h with Hanger Cap — Epic International (Thailand) Co., Ltd. · Class IIa
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 4c7f3ada-6a3b-4e6d-b2f7-0be66784c741 61 fields · synced Jun 18, 2026