Data / Medical devices / Malaysia / Dexcom (Malaysia) Sdn. Bhd.
Dexcom (Malaysia) Sdn. Bhd.: FDA-registered device maker in Bandar Cassia Pulau Pinang, Malaysia, 3 510(k) clearances
Dexcom (Malaysia) Sdn. Bhd. is registered with the FDA (registration 3027503105) in Bandar Cassia Pulau Pinang, Malaysia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027503105
- Address
- PMT 818, Persiaran Cassia Selatan 3 Taman Perindustrian Batu Kawan, Bandar Cassia Pulau Pinang, Malaysia, 14110
- Owner or operator
- DEXCOM, INC. (9071756)
- Roles
- Manufacturer
- First device listed
- July 17, 2026
- Registered through
- 2027
- Brand names listed
- Dexcom G7 15 Day Continuous Glucose Monitoring System, Dexcom G7 Continuous Glucose Monitoring System, Stelo
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | SBH | 2 | Manufacturer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | SAF | 2 | Manufacturer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K260935 | Stelo Glucose Biosensor System | SBH | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| June 8, 2026 | K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| May 21, 2026 | K261359 | Stelo Glucose Biosensor System | SAF | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
- All makers of Tape And Bandage, Adhesive
- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated
- All makers of Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Updated June 12, 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.