Medipoint Blood Lancets
Medipoint Blood Lancets are handheld instruments that puncture the fingertip to obtain a small capillary blood sample for testing. Each lancet is made from a single piece of stainless…
Medipoint Blood Lancets are handheld instruments that puncture the fingertip to obtain a small capillary blood sample for testing. Each lancet is made from a single piece of stainless steel.
A sharp beveled tip pierces the skin, while a knurled section provides a grip for manual control. The lancet is used directly as a skin-puncture instrument.
Sterile Single-Use Supply
Each lancet is individually enclosed in a paper package and sterilized in that package using moist heat. It is intended for one use and is discarded into a sharps container immediately afterward. The design does not include an integral sharps injury prevention mechanism.
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 | Medipoint Holdings, LLC, United States |
|---|---|
| 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 | Complaint-file establishment, Manufacturer |
| 510(k) | K223480 |
| Record published | 2023-02-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 195701000 | 1,000 | In distribution | |
| 19570200 | 200 | 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 |
|---|---|
| K223480 | 2023-01-13 |
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.