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, hor
| Company | Devices | Share |
|---|---|---|
| Owen Mumford Usa Incorporated | 217 | 20% |
| Htl Strefa S A | 73 | 7% |
| Ultimed, Inc. | 64 | 6% |
| Promisemed Hangzhou Meditech Co., Ltd. | 55 | 5% |
| Sandstone Medical (Suzhou) Inc. | 42 | 4% |
| Promisemed Medical Devices Inc. | 37 | 3% |
| Medivena, Llc | 33 | 3% |
| Ningbo Medsun Medical Co., Ltd. | 27 | 2% |
| H. E. Butt Grocery Company | 27 | 2% |
| Arkray Usa, Inc. | 27 | 2% |
| Trividia Health, Inc. | 26 | 2% |
| Carelife (Usa) Inc. | 23 | 2% |
Company = labeler of record on GUDID. 66 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 1,037 |
| FMI | Needle, hypodermic, single lumen | 89 |
| NSC | Injector, Pen | 5 |
| FRN | Pump, Infusion | 4 |
| FMF | Syringe, Piston | 1 |
| KZH | Introducer, Syringe Needle | 1 |
Use these as the dimensions to specify in a tender line.
1,085 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Autoinjector needle", from 66 companies. The largest labeler is Owen Mumford Usa Incorporated with 20% of records.
FMI (Needle, Hypodermic, Single Lumen), FMI (Needle, hypodermic, single lumen), NSC (Injector, Pen), FRN (Pump, Infusion)
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.