FDA Registration
Active
🇨🇳 China
Alltion (Guangxi) Instrument Co., Ltd.
Reg #: 3003969012
·
FEI: 3003969012
·
Expires 2026
Products
8
Proprietary Names
63
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- Alltion (Guangxi) Instrument Co., Ltd.
- Registration Number
- 3003969012
- FEI Number
- 3003969012
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.10, 3rd Road, Wuzhou Industrial Park
- City
- Wuzhou City Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K061306
Owner / Operator
- Firm Name
- Alltion (Wuzhou) Co., Ltd.
- Operator Number
- 9055212
- Address
- No.10, 3rd Road, Wuzhou Industrial Park
- City
- Wuzhou City
- State
- Guangxi
- Postal Code
- 543000
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2007-04-13 |
| Colposcope (And Colpomicroscope) | HEX | Class 2 | Obstetrics/Gynecology | No | 2007-04-13 |
| Colposcope (And Colpomicroscope), Exempt | PTZ | Class 2 | Obstetrics/Gynecology | No | 2022-12-28 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2003-02-21 |
| Light, Microscope | IBJ | Class 1 | Pathology | No | 2008-05-08 |
| Headlamp, Operating, Battery-Operated | HPP | Class 1 | Ophthalmic | No | 2007-04-13 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2022-10-25 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2016-12-18 |
Proprietary Names
LOUPE, DIAGNOSTIC/SURGICAL
Colposcope (and Colpomicroscope)
AC-3300 Colposcope
AC-5000 Colposcope
AC-3500 Colposcope
Microscope, Operating & Accessories, AC-Powered, Ophthalmic
Light, Microscope
Headlamp, Operating, Battery-Operated
Angel 240 Surgical Microscope
Angel 160 Surgical Microscope
AM-7020 Surgical Microscope
Angel 65 Surgical Microscope
Angel 170 Surgical Microscope
Angel 190 Surgical Microscope
AM- 6000 Surgical Microscope
AM-5000 Surgical Microscope
Angel 100Pro Surgical Microscope
Angel 200Plus Surgical Microscope
AM-2000Plus Surgical Microscope
Angel 100Plus Surgical Microscope
AM-2000 Surgical Microscope
AM-7200 Surgical Microscope
AM-7000 Surgical Microscope
AM-5000Pro Surgical Microscope
Angel 60 Surgical Microscope
Angel 100 Surgical Microscope
Angel 150 Surgical Microscope
AM-5000Plus Surgical Microscope
TOP-100Plus Surgical Microscope
Angel 180 Surgical Microscope
AM-7400 Surgical Microscope
Angel 70 Surgical Microscope
AM-2000Pro Surgical Microscope
Angel 210 Surgical Microscope
Angel 230 Surgical Microscope
Angel 200Pro Surgical Microscope
AM-7220 Surgical Microscope
Angel 60PF Surgical Microscope
Angel 220 Surgical Microscope
Angel 65P Surgical Microscope
AM-7240 Surgical Microscope
Top-200 Surgical Microscope
Angel 200 Surgical Microscope
Angel 140 Surgical Microscope
Angel 110 Surgical Microscope
AM-2500 Surgical Microscope
Angel 60F Surgical Microscope
Angel 60P Surgical Microscope
Angel 80 Surgical Microscope
Angel 250 Surgical Microscope
Top-100 Surgical Microscope
Angel 70P Surgical Microscope
Angel 80P Surgical Microscope
Angel 75 Surgical Microscope
AM-7260 Surgical Microscope
Angel 75P Surgical Microscope
AM-7420 Surgical Microscope
Angel 90 Surgical Microscope
Angel 90P Surgical Microscope
AM-5000Max Surgical Microscope
Angel 120 Surgical Microscope
Angel 130 Surgical Microscope
Examination Light
Establishment Types
Manufacture Medical Device