Syringe with safety needle

FDA UDI

Class II (US FDA UDI)

by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Identity

Trade Name: Syringe with safety 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: LL - 1ml 25G 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: SLL12525SN FDA UDI
Primary DI / UDI-DI: 06958697602646 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 safety 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Sources (1)

FDA UDI ea0d5ff6-009c-4f69-bbf3-ceff0e508c15 35 fields · synced Jun 6, 2026