Data / Medical devices / Taiwan / Great Group Medical Co Ltd.
Great Group Medical Co Ltd.: FDA-registered device maker in Changhua County, Taiwan, 1 510(k) clearance
Great Group Medical Co Ltd. is registered with the FDA (registration 3008567544) in Changhua County, Taiwan. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 27, 2022. Registered through 2027. FDA data exported November 3, 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.
- FDA registration number
- 3008567544
- Address
- No.168, Xingong 2nd Rd. Tianzhong Township, Changhua County, Taiwan, 52046
- Owner or operator
- Great Group Medical Co Ltd. (10045498)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 24, 2013
- Registered through
- 2027
- Brand names listed
- Artificial nose, GGM Breathing Circuit Bacterial Filter, GGM Disposable Heater Wire Breathing Circuit, Nasal oxygen cannula, Nonrebreathing mask, Respiratory Humidifier, Models VH-2100, VH2600A, and VH-2600, Respiratory gas humidifier, Therapeutic humidifier for home use and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Humidifier Nebulizer Kit | OGG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 27, 2022 | K210352 | GGM Breathing Circuit Bacterial Filter | CAH | Substantially Equivalent | Great Group Medical Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Humidifier, Non-Direct Patient Interface (Home-Use)
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Cannula, Nasal, Oxygen
Updated March 27, 2022. 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.