SteriLance Softsense Lancet 28g
Catalogue number 01-1928, listed by Sterilance Medical (Suzhou) Inc., China, under Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature. 21 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (5), Tianjin (5), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jetcrown Industrial (Dong Guan) Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Taizhou Chenguang Import AND Export Trading Co., Ltd. | Taizhou | Jiangsu | Exporter | 25 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Shanghai Carelife International Trading Co., Ltd. | Jinqiao Pudong | Shanghai | Specification developer | 11 |
| Sterilance Medical (Suzhou) Inc. | Suzhou | Jiangsu | Contract manufacturer | 8 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Showing 12 of 21. All 21 manufacturers in China registered for Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Record
| Listed by | Sterilance Medical (Suzhou) Inc., China |
|---|---|
| FDA product code | QRK |
| Device type | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4850 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Record published | 2024-01-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 01-1928 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TRUEplus | Trividia Health, Inc. | 25 |
| STERiLANCE | Sterilance Medical (Suzhou) Inc. | 9 |
| Accu-Chek Softclix | Roche Diabetes Care, Inc. | 9 |
| Owell | Owell | 6 |
| EasyTouch | MHC Medical Products | 6 |
| OneTouch Delica Plus Lancet | Asahi Polyslider Co., Ltd. | 5 |
| Fora | Fora Care Inc. | 4 |
| STERiLANCE Soft Disposable Blood Lancet | Sterilance Medical (Suzhou) Inc. | 4 |
| Medsun | Ningbo Medsun Medical Co., Ltd. | 4 |
| Soft | Sterilance Medical (Suzhou) Inc. | 4 |
| True Integral | True Integral Inc | 4 |
| 1st Tier Unilet | Owen Mumford USA, Inc. | 3 |
Showing 12 of 85. All products under Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262631 | 2026-08-25 |
| K261634 | 2026-06-12 |
| K244031 | 2025-02-26 |
| K221507 | 2022-08-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.