EUDAMED device

Ultra-Fine Insulin Syringes

EUDAMED device 00383017845735 · embecta Medical II LLC

Key facts

Primary DI 00383017845735
Trade name Ultra-Fine Insulin Syringes
Device name Ultra-Fine
Reference or catalog number 328457
Model Insulin Syringe - Blister
Manufacturer embecta Medical II LLC
Manufacturer SRN US-MF-000044225
Risk class Class IIa
EMDN code A02010601
EMDN description INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE
Legislation mdr
Implantable No
Sterile Yes
Single use Yes
Status date Sep 18, 2025

At a glance

  • No Matching FDA GUDID record

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About EUDAMED devices

EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.

Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date:

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