Consulting Wallah › Device Explorer › Syringes, needles & infusion › Insulin syringe/needle, safety
Device Explorer · FDA GUDID · GMDN 34973

Insulin syringe/needle, safety

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retract

US‑registered devices202in commercial distribution
Companies17labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription48%Rx‑only share
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Share of device records

Berpu Medical Technology Co.,Ltd5226%
Dynarex Corporation3216%
Mhc Medical Products, Llc2412%
Myco Medical Supplies Inc.199%
Mckesson Medical-Surgical Inc.157%
Jiangsu Caina Medical Co.,Ltd105%
Htl Strefa S A94%
Sol-Millennium Medical, Inc.73%

Top labelers

CompanyDevicesShare
Berpu Medical Technology Co.,Ltd5226%
Dynarex Corporation3216%
Mhc Medical Products, Llc2412%
Myco Medical Supplies Inc.199%
Mckesson Medical-Surgical Inc.157%
Jiangsu Caina Medical Co.,Ltd105%
Htl Strefa S A94%
Sol-Millennium Medical, Inc.73%
Medivena, Llc73%
Twin Med, Llc73%
Endure Industries63%
Medline Industries, Inc.42%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InsosafeCardinal HealthMetierDisposable Insulin SyringeRed TunicaEndureSOL-CARE™ Insulin Safety Syringe with Fixed NeedSOL-CARE™ Insulin Syringe w/Fixed NeedleGLUCO-CARE PLUS Pen NeedlesONE-CARE Pen NeedlesONE-CARE Pen Needles,ONE-CARE Safety Pen Needles 30G x 8mm, Yellow,ONE-CARE Safety Pen Needles 30G x 5mm, Pink,SecureSafe Tuberculin Safety SyringeSecure Safe Allergy TraySecureSafe Syringe With Safety Needle

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

FDA product codes

CodeNameDevices
MEGSyringe, Antistick100
FMFSyringe, Piston94
FMINeedle, Hypodermic, Single Lumen42
MEGSYRINGE, ANTISTICK13
FMFSyringe, piston8
FMINeedle, hypodermic, single lumen5

GMDN & GCC registration

  • GMDN code 34973 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 48% · OTC 11%
  • 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) · 56Total Volume (Milliliter) · 48Length (Inch) · 33Length (Millimeter) · 18Catheter Length (Millimeter) · 6Outer Diameter (Inch) · 5

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

How many insulin syringe/needle, safety products are registered in the US?

202 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Insulin syringe/needle, safety", from 17 companies. The largest labeler is Berpu Medical Technology Co.,Ltd with 26% of records.

Which FDA product codes apply?

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