Data / Medical devices / Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (PZE): 9 FDA-registered makers in 6 countries
9 establishments in 6 countries are registered with the FDA to make Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE, Class 3). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- PZE
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Ireland | 2 |
| United Kingdom | 1 |
| Poland | 1 |
| Mexico | 1 |
| China | 1 |
Makers of Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
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, Specification developer | 0 | 1 | 1 | 1 | api.fda.gov | |
| Abbott Diabetes Care Limited | WITNEY OXON Oxfordshire, United Kingdom | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| RR Donnelley GTS Poland Sp. z o.o. | Lodz Lodzkie, Poland | Contract manufacturer, Exporter to the US | 0 | 1 | 0 | 0 | api.fda.gov | |
| Flextronics International USA | Buffalo Grove, IL, United States | Manufacturer for export | 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 November 2, 2026. 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.