Data / Medical devices / China / Alltion (Guangxi) Instrument Co., Ltd.
Alltion (Guangxi) Instrument Co., Ltd.: FDA-registered device maker in Wuzhou City Guangxi, China, 1 510(k) clearance
Alltion (Guangxi) Instrument Co., Ltd. is registered with the FDA (registration 3003969012) in Wuzhou City Guangxi, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003969012
- Address
- No.10, 3rd Road Wuzhou Industrial Park, Wuzhou City Guangxi, China, 543000
- Owner or operator
- Alltion (Wuzhou) Co., Ltd. (9055212)
- Roles
- Manufacturer
- First device listed
- February 21, 2003
- Registered through
- 2026
- Brand names listed
- AC-3300 Colposcope, AC-3500 Colposcope, AC-5000 Colposcope, AM-2000 Surgical Microscope, AM-2000Plus Surgical Microscope, AM-2000Pro Surgical Microscope, AM-2500 Surgical Microscope, AM-5000 Surgical Microscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 2 | Manufacturer | accessdata.fda.gov |
| Colposcope (And Colpomicroscope), Exempt | PTZ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Medical Examination, Ac Powered | KZF | 1 | Manufacturer | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Manufacturer | accessdata.fda.gov |
| Light, Microscope | IBJ | 1 | Manufacturer | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 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 |
|---|---|---|---|---|---|---|
| August 7, 2006 | K061306 | CO-1000 COLPOSCOPE, MULTIPLE | HEX | Substantially Equivalent | Gynex Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Colposcope (And Colpomicroscope)
- All makers of Device, Medical Examination, Ac Powered
- All makers of Light, Microscope
- All makers of Colposcope (And Colpomicroscope), Exempt
- All makers of Loupe, Diagnostic/Surgical
- All makers of Headlamp, Operating, Battery-Operated
Updated August 7, 2006. 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.