Skip to content

Infusion pump for single use CBI 100ml 2ml/h

by Jiangxi Hongda Medical Equipment Group Ltd.

Ref CBI100-2Model 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)]）

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69207567SZB0001TQ Basic UDI-DI 66920756721607UDI-DIDate11 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Infusion pump for single use
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)]）, CBI100-2
Primary DI / UDI-DI
66920756721607
Basic UDI-DI
69207567SZB0001TQ
EMDN Code
A05010101 Elastomeric systems - fixed flow w/o additional bolus
Device Class
Class IIa
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000006019
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Elastomeric infusion pump system

Other devices from Jiangxi Hongda Medical Equipment Group Co., Ltd.

See all devices from Jiangxi Hongda Medical Equipment Group Co., Ltd. →

Properties

  • Sterile
  • Administering Medicine
  • Measuring Function

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Incorporates Medicinal Product: No