FDA Registration
Active
🇨🇳 China
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3012336822
·
FEI: 3012336822
·
Expires 2026
Products
13
Proprietary Names
15
Establishment Types
1
Classifications
13
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Registration Details
- Registration Name
- GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3012336822
- FEI Number
- 3012336822
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.301,401,501 of Building 3, Wanyang Kexing Park, No. 84 Taoyuan East Road, Shishan Town, Nanhai District
- City
- Foshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K170236
Owner / Operator
- Firm Name
- Guangdong JINME Medical Technology Co., Ltd.
- Operator Number
- 10051074
- Address
- No.301,401,501 of Building 3, Wanyang Kexing Park, No. 84 Taoyuan East Road, Shishan Town, Nanhai District
- City
- Foshan
- State
- Guangdong
- Postal Code
- 528225
- Country
- CN
- Correspondent
- Kristi Yang
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St Flushing, NY
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 2024-04-15 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2024-07-02 |
| Unit, Suction Operatory | EBR | Class 1 | Dental | No | 2023-09-15 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2023-09-15 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2018-01-10 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2018-01-10 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2024-07-02 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2023-09-07 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2024-02-04 |
| Intraoral Camera | QJK | Class 2 | Dental | No | 2023-05-30 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2023-05-30 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2024-09-03 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2024-09-03 |
Proprietary Names
Dental Burs
Dental air compressor
Suction machine (model: suction 10, suction 20)
Air compressor (model: Air compressor)
Testing machine (model: HP Tester)
Dental Low-Speed Turbine Handpiece (Model: LN, L)
Dental High-Speed Turbine Handpiece (Model: T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP)
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Saw blade (model: S-10W, S-6W, R-30T, R-20T, R-15T, O-15.5L, O-10.5L, HG558, HF113 040HP, HF119 016HP)
Dental chair and accessories (Model: S600, S690, S610)
Intra Oral Camera (Model: ECO-CAMERA 01, ECO-CAMERA 02, ECO-CAMERA 03)
Intra Oral Scanner (Model: ECO-SCANNER 1, ECO-SCANNER 2)
Surgical Drive System (model: ES70, ES90, E8)
Surgical Drive System ES90 Kit (model: ES90 K1, ES90 K2, ES90 K3)
Surgical Drive System ES70 Kit (model: ES70 K1, ES70 K2)
Establishment Types
Manufacture Medical Device