A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. I
| Company | Devices | Share |
|---|---|---|
| Sterilance Medical (Suzhou) Inc. | 116 | 26% |
| Owen Mumford Limited | 39 | 9% |
| Medipurpose Pte. Ltd. | 39 | 9% |
| Medivena, Llc | 27 | 6% |
| Hebei Xinle Sci&Tech Co., Ltd. | 24 | 5% |
| Home Aide Diagnostics, Inc. | 17 | 4% |
| Mhc Medical Products, Llc | 15 | 3% |
| Owens & Minor Distribution, Inc. | 14 | 3% |
| Medline Industries, Inc. | 13 | 3% |
| Asahi Polyslider Company,Limited | 9 | 2% |
| Arkray Usa, Inc. | 9 | 2% |
| Tianjin Huahong Technology Co., Ltd. | 8 | 2% |
Company = labeler of record on GUDID. 53 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 |
|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury | 230 |
| FMK | Lancet, Blood | 160 |
| FMK | Lancet, blood | 36 |
| FMK | Single use only blood lancet with an integral sharps injury | 26 |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Inju | 8 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 7 |
Use these as the dimensions to specify in a tender line.
443 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual blood lancing device, single-use", from 53 companies. The largest labeler is Sterilance Medical (Suzhou) Inc. with 26% of records.
FMK (Single Use Only Blood Lancet With An Integral Sharps Injury ), FMK (Lancet, Blood), 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.