Syringe with needle

FDA UDI

Class II (US FDA UDI)

by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Identity

Trade Name: Syringe with needle FDA UDI
Generic Name: Metered-delivery hypodermic syringe FDA UDI
Device Name: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. FDA UDI
Model / Reference: LS - 1ml 23G X 1" FDA UDI
Description: A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device. FDA UDI

Identifiers

Catalog Number: T1ML2325E FDA UDI
Primary DI / UDI-DI: 06958697602752 FDA UDI
510(k) Number: K190183 FDA UDI
FDA Product Code: MEG FDA UDI
GMDN Term: Metered-delivery hypodermic syringe 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

FDA UDI

Category: Metered-delivery hypodermic syringe

Syringe with needle by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metered-delivery hypodermic syringe.

TERUMO — Terumo (Philippines) Corporation · Class II
SURGUARD2 — Terumo (Philippines) Corporation · Class II
ZevRx STERILE INSULIN SYRINGE 5/16” | 1/2CC | 30G — HOME AIDE DIAGNOSTICS, INC. · Class II
Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
Monoject — Cardinalhealth · Class II
Jelco — ICU MEDICAL, INC. · Class II
Monoject — Cardinalhealth · Class II

Cleared under the same submission

K190183 also covers:

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: Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Sources (1)

FDA UDI 2e79b5f7-07c0-4a6a-853d-ee13bc9a5871 35 fields · synced Jun 8, 2026