Data / Medical devices / Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (QLG): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG, Class 2, 21 CFR 862.1355). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on March 1, 2023, and lists 7 recall events (3 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- QLG
- Device class
- 2
- Regulation
- 862.1355
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Ireland | 3 |
| United Kingdom | 1 |
| Poland | 1 |
| Mexico | 1 |
| China | 1 |
Makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | May 26, 2022 | 0 | 5 | 3 | api.fda.gov |
| Abbott Diabetes Care Limited | WITNEY OXON Oxfordshire, United Kingdom | Manufacturer | 5 | May 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| RR Donnelley GTS Poland Sp. z o.o. | Lodz Lodzkie, Poland | Contract manufacturer, Exporter to the US | 1 | June 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Abbott Ireland, ADC Kilkenny | Kilkenny, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics America, LLC | Austin, TX, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics International USA | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing Aguascalientes, S.A de C.V | Aguascalientes, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina Ireland UC | FERMOY, CORK Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tech Group Europe Limited t/a West | Mulhaddart Dublin(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.