A hand-held manual instrument intended to be used for controlled skin puncture to obtain a capillary blood specimen (e.g., performed by a diabetic patient) typically at the fingertip or ear lobe. It is used with a sterile, disposable lancet tip, and has a manu
| Company | Devices | Share |
|---|---|---|
| Roche Diabetes Care Gmbh | 27 | 16% |
| Shandong Lianfa Medical Plastic Products Co.,Ltd | 20 | 12% |
| Sterilance Medical (Suzhou) Inc. | 14 | 8% |
| Tianjin Huahong Technology Co., Ltd. | 10 | 6% |
| Prodigy Diabetes Care, Llc | 8 | 5% |
| Trividia Health, Inc. | 6 | 4% |
| Mio Labs Inc. | 5 | 3% |
| Ningbo Medsun Medical Co., Ltd. | 4 | 2% |
| Roche Diagnostics Operations, Inc. | 4 | 2% |
| Fora Care Inc. | 3 | 2% |
| Asp Global, Llc | 3 | 2% |
| Owen Mumford Usa Incorporated | 3 | 2% |
Company = labeler of record on GUDID. 55 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 |
|---|---|---|
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 99 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Inju | 35 |
| FMK | Lancet, Blood | 33 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury | 9 |
| NBW | System, Test, Blood Glucose, Over The Counter | 8 |
| CGA | Glucose Oxidase, Glucose | 6 |
Use these as the dimensions to specify in a tender line.
166 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual blood lancing device, reusable", from 55 companies. The largest labeler is Roche Diabetes Care Gmbh with 16% of records.
QRL (Multiple Use Blood Lancet For Single Patient Use Only), QRK (Single Use Only Blood Lancet Without An Integral Sharps Inju), FMK (Lancet, Blood), FMK (Single Use Only Blood Lancet With An Integral Sharps Injury )
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.