Micro-Fine™ Insulin Syringes

Device Name

Insulin Syringe

Model / Reference

31G, 0.5ml 0.25×8mm U-100

Primary DI / UDI-DI

06977201149316

Basic UDI-DI

69721840500097N

EMDN Code

A02010601 Insulin syringes with fixed needle, single-use

Device Class

Class IIa

Market of Registration

Netherlands

EUDAMED SRN

CN-MF-000016465

Authorised representative

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

• Infusion sets for single use with pressure infusion apparatus (Without Needle)(Infusion Sets with Light Resistant Function)

  Class IIa

  CE/MDR

• Administration Set

  Class IIa

  CE/MDR

• Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

  Class II

  FDA 510(k) K231363 Active Cleared 27 Sep 2023

• Disposable Medical Safety Hypodermic Needle

  Class II

  FDA 510(k) K220603 Active Cleared 23 Aug 2022

• Disposable Medical Masks

  Class II

  FDA 510(k) K221038 Active Cleared 1 Sep 2022

• Disposable Insulin Pen Needle

  Class II

  FDA 510(k) K222739 Active Cleared 6 Apr 2023

See all devices from Hantech Medical Device Co., Ltd. →