Alltion (Guangxi) Instrument Co., Ltd.
Registered establishment in Wuzhou, Guangxi, China. 8 device types.
Alltion (Guangxi) Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Light, Microscope, Microscope, Surgical and 6 other device types. Its earliest product listing with the FDA dates from 2003.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3003969012 |
| FEI number | 3003969012 |
| Establishment type | Manufacturer |
Location
| City | Wuzhou |
|---|---|
| Province | Guangxi |
| Address | No.10, 3rd Road |
| Postal code | 543000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | Class 2 | Colposcope (and Colpomicroscope) | 2007 | 4 |
| Colposcope (And Colpomicroscope), Exempt | Class 2 | AC-3500 Colposcope, AC-5000 Colposcope, AC-3300 Colposcope | 2022 | 4 |
| Device, Medical Examination, Ac Powered | Class 1 | Examination Light | 2016 | 18 |
| Headlamp, Operating, Battery-Operated | Class 1 | Headlamp, Operating, Battery-Operated | 2007 | 4 |
| Light, Microscope | Class 1 | Light, Microscope | 2008 | 19 |
| Loupe, Diagnostic/Surgical | Class 1 | Loupe, Diagnostic/Surgical | 2007 | 15 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | Class 1 | Microscope, Operating & Accessories, AC-Powered, Ophthalmic | 2003 | 12 |
| Microscope, Surgical | Class 1 | AM-5000Pro Surgical Microscope, AM-2000Plus Surgical Microscope, Angel 200Pro Surgical Microscope, AM-2000 Surgical Microscope, Angel 200Plus Surgical Microscope, Angel 100Pro Surgical Microscope and 19 more | 2022 | 9 |
Clearances
No clearance names Alltion (Guangxi) Instrument Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K061306 | 2006-08-07 | HEX | Traditional | Gynex Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1995 |
|---|---|
| Main products | Surgical operation microscopes, Dental microscopes, Colposcopes, Medical exam lights |
| Certifications | FDA, CE, ISO 13485, RoHS, UL |
| Export markets | Europe, United States, Japan, Australia |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Micowey Medical Equipment Guangxi Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.