FDA Registration
Active
🇨🇳 China
GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD
Reg #: 3036269993
·
FEI: 3036269993
·
Expires 2026
Products
17
Proprietary Names
19
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD
- Registration Number
- 3036269993
- FEI Number
- 3036269993
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F, Kechuan Blgd, 25-1, Keyuan Road
- City
- Nanning Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242646
Owner / Operator
- Firm Name
- Guangxi Ehall Medical Technology Co.,Ltd
- Operator Number
- 10092754
- Address
- 6F, Kechuan Blgd, 25-1, Keyuan Road
- City
- Nanning
- State
- Guangxi
- Postal Code
- 530012
- Country
- CN
- Correspondent
- Sophie Su
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retractor, All Types | EIG | Class 1 | Dental | No | 2025-02-14 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2025-02-14 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-02-14 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-02-14 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2025-02-14 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2025-02-14 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2025-02-14 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2025-02-14 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2025-02-14 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2025-02-14 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2025-02-14 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2025-02-14 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2025-02-14 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2025-02-14 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2026-04-01 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2025-02-14 |
| Device, Heat-Sealing | KSD | Class 1 | Hematology | No | 2025-02-14 |
Proprietary Names
Cheek Retractor, Silicone Cheek Retractor
Painless Anaesthesia Device
Mixing Tip, Mixing Bowl, Mixing Spatula, Mixing Gun, Mixing pad
Ultrasonic Cleaner
Prophy cup, Nylon Prophy Brush, Prophy Angle, Proply Motor X1
Dental Implant Torque Wrench
Micro Applicator, Adhesive Tip
Fog Free Mirror, Dental Loupe
Orthodontic Braket, Orthodontic Buccal Tube, Orthodontic Elastic, Orthodontic Arch Wires, Dental Teeth Model,
Orthodontic Kit
Dental Box, Denture Box, Cotton Roll Dispenser
Disposable Irrigation Needle, Irrigation Syringe System, Disposable Dental Syringe, Pre-Bent Needle Tip,
Capillary Tip, 3 Way Air Syringe, Air Water Syringe, Saliva Ejector
Composite Heater
Cotton Roll, Cotton Gauze, Dental Dib, Face Protetive Paper
Absorbent Paper Points, Gutta Percha Points
Dental Implant Unit
Plastic Sleeve, Barrier Film, Handpiece Sleeve
Sealed Machine
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device