Accu-Chek Softclix
Accu-Chek Softclix Kit Canada
21manufacturers in China registered for this device type
1catalogue number
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 | Roche Diagnostics Operations, 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 |
| Record published | 2023-03-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09917764001 | 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
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.