Consulting Wallah › Device Explorer › Syringes, needles & infusion › Hypodermic needle, single-use
Device Explorer · FDA GUDID · GMDN 59230

Hypodermic needle, single-use

A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also

US‑registered devices3,088in commercial distribution
Companies103labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Wuxi Yushou Medical Appliances Co.,Ltd.39813%
Anhui Tiankang Medical Technology Co., Ltd.1525%
Tsk Laboratory, Japan1405%
Feeltech Co.,Ltd.1354%
Myco Medical Supplies Inc.1214%
Henke-Sass, Wolf Gmbh1204%
Cardinal Health 200, Llc1154%
Terumo (Philippines) Corporation1114%

Top labelers

CompanyDevicesShare
Wuxi Yushou Medical Appliances Co.,Ltd.39813%
Anhui Tiankang Medical Technology Co., Ltd.1525%
Tsk Laboratory, Japan1405%
Feeltech Co.,Ltd.1354%
Myco Medical Supplies Inc.1214%
Henke-Sass, Wolf Gmbh1204%
Cardinal Health 200, Llc1154%
Terumo (Philippines) Corporation1114%
Becton, Dickinson And Company1023%
Icu Medical, Inc.893%
Mhc Medical Products, Llc843%
Mckesson Medical-Surgical Inc.843%

Company = labeler of record on GUDID. 103 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CareTouchDispomedGBUKMediDentMicsafemicsafeDPSCAINAYeso medYeso-medSOL-Guard Safety NeedleSafety Needlesafety hypodermic needleshypodermic needlesNATianzi

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FMINeedle, Hypodermic, Single Lumen2,070
FMINeedle, hypodermic, single lumen794
FMFSyringe, Piston547
MEGSyringe, Antistick141
GAANeedle, Aspiration And Injection, Disposable95
MEGSYRINGE, ANTISTICK65

GMDN & GCC registration

  • GMDN code 59230 · non‑implantable
  • Single‑use 100% · sterile 98% · Rx‑only 76% · OTC 9%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 877Length (Inch) · 617Length (Millimeter) · 502Outer Diameter (Millimeter) · 258Total Volume (Milliliter) · 73Catheter Length (Inch) · 27

Use these as the dimensions to specify in a tender line.

How many hypodermic needle, single-use products are registered in the US?

3,088 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Hypodermic needle, single-use", from 103 companies. The largest labeler is Wuxi Yushou Medical Appliances Co.,Ltd. with 13% of records.

Which FDA product codes apply?

FMI (Needle, Hypodermic, Single Lumen), FMI (Needle, hypodermic, single lumen), FMF (Syringe, Piston), MEG (Syringe, Antistick)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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