CareSens N (MedPoint Diagnostics)
CareSens N Blood Glucose Meter
20manufacturers in China registered for this device type
1catalogue number
21510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | I-Sens, Inc., South Korea |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K083468 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 32 to 122 °F |
| Packaging | Master case carton of 60 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 155300-201 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230625 | 2023-08-10 |
| K201394 | 2021-10-05 |
| K192859 | 2020-01-24 |
| K193590 | 2020-01-17 |
| K192220 | 2019-12-13 |
| K181273 | 2018-11-01 |
| K180866 | 2018-08-31 |
| K171480 | 2017-12-13 |
| K170614 | 2017-10-19 |
| K160742 | 2016-12-16 |
| K151164 | 2015-08-07 |
| K133346 | 2013-12-19 |
| K132288 | 2013-11-22 |
| K130696 | 2013-08-21 |
| K131419 | 2013-08-09 |
| K121133 | 2012-07-10 |
| K120351 | 2012-05-03 |
| K103396 | 2011-09-27 |
| K100937 | 2010-12-21 |
| K083468 | 2009-02-10 |
| K080923 | 2008-10-17 |
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.