← Back to catalogue
Infusion pump for single use CBI 275ml 2ml/h
EUDAMEDClass IIa (EU MDR)
Ref CBI275-2Model Model:CBI、CBI+PCA ；Filing volume：100mL、150mL、 200mL、275mL；Nominal flow rate：2mL/h、3mL/L、 4mL/h、5mL/L；[Bolus volume：0.5mL/times;Bolus refill time：15min （Only applicable to CBI+PCA)]）
Identity
- Trade Name
- Infusion pump for single use CBI 275ml 2ml/h EUDAMED
- Device Name
- Infusion pump for single use EUDAMED
- Model / Reference
- Model:CBI、CBI+PCA ；Filing volume：100mL、150mL、 200mL、275mL；Nominal flow rate：2mL/h、3mL/L、 4mL/h、5mL/L；[Bolus volume：0.5mL/times;Bolus refill time：15min （Only applicable to CBI+PCA)]） EUDAMEDCBI275-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756726039 EUDAMED
- Basic UDI-DI
- 69207567SZB0001TQ EUDAMED
- EMDN Code
- A05010101 ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Elastomeric infusion pump system
Infusion pump for single use CBI 275ml 2ml/h by Jiangxi Hongda Medical Equipment Group Ltd. — 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
- Neofuser Duo — S&S Med Co.,Ltd. · Class IIb
- Elastomeric Infusion Pump — Poly Medicure Limited · Class IIb
- Infusion Pump — Henan Tuoren Medical Device 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
- CareVis VariO TwiN — S&S Med Co.,Ltd. · Class IIb
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 | 69207567SZB0001TQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0bf57c1f-bff8-4e3b-a715-6d28c1dcf80f 61 fields · synced Oct 6, 2026