3ml Suresafe Syringe

FDA UDI

Class II (US FDA UDI)

by Dmc Medical Limited

Identity

Trade Name: 3ml Suresafe Syringe FDA UDI
Generic Name: Metered-delivery hypodermic syringe/needle FDA UDI
Device Name: 3ml Suresafe Automatic Retractable Syringe - 23G x 1" - Sterile FDA UDI
Model / Reference: 3ml Syringe - 23G x 1" FDA UDI
Description: 3ml Suresafe Automatic Retractable Syringe - 23G x 1" - Sterile FDA UDI

Identifiers

Catalog Number: FD-SSIC03-23 FDA UDI
Primary DI / UDI-DI: 05391530750394 FDA UDI
510(k) Number: K143497 FDA UDI
FDA Product Code: MEG FDA UDI
GMDN Term: Metered-delivery hypodermic syringe/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Metered-delivery hypodermic syringe/needle

3ml Suresafe Syringe by Dmc Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metered-delivery hypodermic syringe/needle.

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Magellan — Cardinal Health 200, LLC · Class II
VanishPoint® — Retractable Technologies, Inc. · Class II
BD Integra — BECTON DICKINSON AND COMPANY · Class II
VanishPoint® — Retractable Technologies, Inc. · Class II
Securegard — SafeGard Medical /Hungary/ Gyogyaszati Eszkozgyarto es Forgalmazo Korlatolt Felelossegu Tarsasag · Class II
Safety Syringe w/Needle — Dynarex Corp. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dmc Medical Limited

Sources (1)

FDA UDI 83760947-7844-4e6b-8d9b-a758099797e5 35 fields · synced May 30, 2026