← Back to catalogue
Elastomeric Infusion pump
EUDAMEDClass IIa (EU MDR)
Ref 14725Model Elastomeric Infusion Pump
Identity
- Trade Name
- Elastomeric Infusion pump EUDAMED
- Device Name
- Elastomeric Infusion Pump EUDAMED
- Model / Reference
- Elastomeric Infusion Pump EUDAMED14725 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095147252 EUDAMED
- Basic UDI-DI
- 890209514450EV EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS 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
Category: Elastomeric infusion pump system
Elastomeric Infusion pump by Poly Medicure Limited — Class IIa — 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 | 890209514450EV | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8f41c1d9-0ca8-428b-8f2b-026a2ce678c1 61 fields · synced Jul 9, 2026