My Dose Coach
Insulin Titration App
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
Record
| Listed by | Sanofi-Aventis Deutschland GmbH |
|---|---|
| FDA product code | NDC |
| Device type | Calculator, Drug Dose |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| 510(k) | K163099 |
| Record published | 2017-06-02 |
| Record revised | 2026-07-21 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: No storage conditions |
| Distribution end date | 2023-03-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.x.x | Withdrawn | |
| 2.x.x | No size – Software as a Medical Device | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welldoc | Welldoc | 16 |
| Insulia | Voluntis | 6 |
| Healthfirst Cares Rx | Welldoc | 6 |
| Bluestar | Welldoc | 6 |
| Healthfirst Cares | Welldoc | 5 |
| Conifer Connect Diabetes | Welldoc | 5 |
| Welldoc Rx | Welldoc | 5 |
| LivingConnected Diabetes Rx | Welldoc | 5 |
| Bluestar Rx | Welldoc | 5 |
| Conifer Connect Diabetes Rx | Welldoc | 5 |
| inpen™ | Medtronic Minimed | 5 |
| TempoSmart | Welldoc | 4 |
Showing 12 of 36. All products under Calculator, Drug Dose
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.