FDA Registration
Active
🇨🇳 China
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
Reg #: 3016075921
·
FEI: 3016075921
·
Expires 2026
Products
7
Proprietary Names
6
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3016075921
- FEI Number
- 3016075921
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.8-3, Information Industrial Park, High-Tech Zone, Qixing District
- City
- Guilin Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230641
Owner / Operator
- Firm Name
- Guilin Refine Medical Instrument Co., LTD.
- Operator Number
- 10064688
- Address
- No. 8-3, Information Industrial Park High-Tech Zone, Qixing District
- City
- Guilin
- State
- Guangxi
- Postal Code
- 541004
- Country
- CN
- Correspondent
- Rong Wen
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2024-01-05 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2023-11-19 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2020-10-24 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2026-04-21 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2023-11-19 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2022-06-07 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2022-06-02 |
Proprietary Names
Ultrasonic Activator (Model: VAT-3)
External Oral Aerosol Suction System
Portable Dental X-ray Device (Model: GT-1)
Curing Light (Model: MaxCure9)
Dental Prophylaxis Powder, Model: PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7
Gutta Percha Obturation System, MaxFill-G, MaxFill-P
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)