Disposable Automatically Retractable Safety Syringe (with fixed 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.

Device Name

Disposable Safety Syringes (with fixed needle)

Model / Reference

0.5ml 1ml 3ml 5ml 10ml 20ml, SSFN10-20-01

Primary DI / UDI-DI

06971603582016

Basic UDI-DI

697160358WDSSQ6

EMDN Code

A02010205 Infusion and irrigation syringes with safety system, single-use

Device Class

Class IIa

EU market of registration

Türkiye

EUDAMED SRN

CN-MF-000020619

Authorised representative

Lotus NL B.V. NL-AR-000000121

• Disposable Syringes (with needle)

  Class IIa

  CE/MDR

• Disposable Automatically Retractable Safety Syringe ( with exchangable needle )

  Class IIa

  CE/MDR

• Disposable Insulin Syringe

  Class IIa

  CE/MDR

• Disposable Hypodermic Needle

  Class IIa

  CE/MDR

• ENFit Reusable Enteral Syringe

  Class II

  FDA 510(k) K203613 Active Cleared 27 Aug 2021

• ENFit Disposable Enteral Syringe

  Class II

  CE/MDR FDA 510(k) K203410 Active Cleared 28 Jun 2021

See all devices from Shantou Wealy Medical Instrument Co., Ltd. →