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Disposable infusion pump
EUDAMEDClass IIb (EU MDR)
Ref E250002002Model SZB-CX-F 250mL/2mL/h
Identity
- Trade Name
- Disposable infusion pump EUDAMED
- Device Name
- Disposable infusion pump EUDAMED
- Model / Reference
- SZB-CX-F 250mL/2mL/h EUDAMEDE250002002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952803712328 EUDAMED
- Basic UDI-DI
- B-06952803712328 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
Disposable infusion pump by Zhejiang Fert Medical Device Co., Ltd. — Class IIb — MDD — 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
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06952803712328 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Fert Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000012602
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 85ca363d-2212-43dd-8b74-8f0680156096 61 fields · synced Jul 9, 2026