Thera Plus
Lancing Device 1CT
21manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (5), Tianjin (5), Jiangsu (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 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| 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 Multiple Use Blood Lancet For Single Patient Use Only
Record
| Listed by | Fourstar Group, Hong Kong |
|---|---|
| FDA product code | QRL |
| Device type | Multiple Use Blood Lancet For Single Patient Use Only |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4850 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K222472 |
| Record published | 2023-10-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64431942B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Twist Lancet (23G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 24 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 18 |
| Twist Lancet (28G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 13 |
| Twist Lancet (30G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 12 |
| Twist Lancet (26G) | Shandong Lianfa Medical Plastic Products Co., Ltd. | 11 |
| Care Touch | Tianjin Huahong Technology Co., Ltd. | 10 |
| TysonBio | Shandong Lianfa Medical Plastic Products Co., Ltd. | 8 |
| Accu-Chek Fastclix | Roche Diabetes Care, Inc. | 8 |
| TRUEdraw | Trividia Health, Inc. | 7 |
| Right Lance | Beijing Ruicheng Medical Supplies Co., Ltd. | 5 |
| Huahong | Tianjin Huahong Technology Co., Ltd. | 5 |
| One +Step | Shandong Lianfa Medical Plastic Products Co., Ltd. | 4 |
Showing 12 of 103. All products under Multiple Use Blood Lancet For Single Patient Use Only
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Home Health US Incorporated | 510(k) number | 2025-07-25 | Class III | Error in labeling | Due to incorrect/lack of Unique Device Identifier (UDI) codes. | 4,661 lancets |
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.