Infusion Sets for Single Use (with Needle)

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

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

Trade Name

Infusion Sets for Single Use (with Needle)

Infusion Sets for Single Use (without Needle)

Model / Reference

IS-GA1, IS-GA2，IS-GB1，IS-GB2，IS-GC1，IS-GC2, 8106, Infusion Sets for Single Use (without Needle), IS-GC2

Primary DI / UDI-DI

06953124681065

Basic UDI-DI

695312468101FZ, 69531246SYQ5R

EMDN Code

A03010101, A03010102

Device Class

Class IIa

Class I

EU market of registration

Romania

EUDAMED SRN

CN-MF-000037484

Authorised representative

Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

• Infusion Sets for Single Use (without Needle)

  Class I

  CE/MDR

• Sterile Hypodermic Syringes for Single Use (without Needle)

  Class I

  CE/MDR

• Disposable sterile irrgation syringe

  Class I

  CE/MDR

• Disposable Transfusion Set (without Needle)

  Class I

  CE/MDR

• Sterile Hypodermic Syringes for Single Use (with needle)

  Class IIa

  CE/MDR

• Disposable Sterile Hypodermic Needles

  Class IIa

  CE/MDR

See all devices from Jiangsu Zhengkang Medical Apparatus Co., Ltd. →