Insulin Pen Needle

FDA UDI

Class II (US FDA UDI)

by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Identity

Trade Name: INSULIN PEN NEEDLE FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device. FDA UDI
Model / Reference: 31G x 5MM FDA UDI
Description: A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device. FDA UDI

Identifiers

Catalog Number: HWIPN3105 FDA UDI
Primary DI / UDI-DI: 06958697605845 FDA UDI
510(k) Number: K133058 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 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: Autoinjector needle

Insulin Pen 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 Autoinjector needle.

Unifine Ultra — OWEN MUMFORD USA INCORPORATED · Class II
MICRON, droplet pen needle — HTL STREFA S A · Class II
SureFine Pen Needle 31Gx8mm — SHINA MED CORPORATION · Class II
EasyDrip Pen Needles 30G 8mm — Sandstone Medical (Suzhou) Inc. · Class II
droplet®, pen needles — HTL STREFA S A · Class II
Nano 2nd Gen — embecta Medical II LLC · Class II
BD Ultra-Fine — BECTON DICKINSON PEN LIMITED · Class II
Insulin Pen Needle — Berpu Medical Technology Co., Ltd · 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

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 9bcc01d2-8a59-4fc8-9fc2-ae95cf28c15d 35 fields · synced Jun 7, 2026