HemoCue® Glucose 201 DM Analyzer
HemoCue Glucose 201 DM Analyzer mmol/L plasma
5manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Tianjin (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | Hemocue AB, Sweden |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Manufacturer |
| 510(k) | K041230 |
| Record published | 2016-05-31 |
| Record revised | 2022-10-31 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Special storage condition: Storage in <90 % non-condensing humidity; Storage environment temperature 32 to 122 °F; Storage environment temperature 0 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 121444 | In distribution | |
| 121422 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 15 |
| Contour® | Ascensia Diabetes Care US Inc. | 10 |
| Fora | Fora Care Inc. | 9 |
| Contour® Next ONE | Ascensia Diabetes Care US Inc. | 9 |
| True Metrix GO | Trividia Health, Inc. | 8 |
| OneTouch Verio | Lifescan Europe Gmbh | 8 |
| Accu-Chek Aviva Plus | Roche Diagnostics Operations | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Accu-Chek Guide | Roche Diagnostics Operations | 7 |
| Contour® Next | Ascensia Diabetes Care US Inc. | 6 |
| Accu-Chek Smart View | Roche Diagnostics Operations | 6 |
| FreeStyle Lite | Abbott Diabetes Care Limited | 5 |
Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060765 | 2006-09-06 |
| K041230 | 2004-05-20 |
| K962415 | 1996-10-15 |
| K961311 | 1996-08-23 |
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.