FDA Registration
Active
🇨🇳 China
SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD
Reg #: 3031191035
·
FEI: 3031191035
·
Expires 2026
Products
19
Proprietary Names
20
Establishment Types
3
Classifications
19
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Registration Details
- Registration Name
- SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD
- Registration Number
- 3031191035
- FEI Number
- 3031191035
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 102, 1st Floor, and Room 202, 2nd Floor, Building 19, Liandong U Valley Life and Health City, No. 80, Tianjingshan 2nd Road, Huanxiu Street, Jimo District
- City
- Qingdao City Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Shandong Hengfeng Kerui Medical Equipment Co., Ltd
- Operator Number
- 10090457
- Address
- Room 102, 1st Floor, and Room 202, 2nd Floor, Building 19, Liandong U Valley Life and Health City, No. 80, Tianjingshan 2nd Road, Huanxiu Street, Jimo District
- City
- Qingdao City
- State
- Shandong
- Postal Code
- 266200
- Country
- CN
- Correspondent
- Heng Chen
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 |
|---|---|---|---|---|---|
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2024-03-31 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2024-09-29 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2024-03-31 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2024-03-31 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2026-06-07 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2024-03-31 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2024-03-31 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-03-31 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2024-03-31 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2024-03-31 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2024-09-29 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2024-03-31 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2026-06-07 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2024-03-31 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2024-03-31 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2024-03-31 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2024-03-31 |
| Floss, Dental | JES | Class 1 | Dental | No | 2024-03-31 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2024-03-31 |
Proprietary Names
Powered Toothbrush
Chewing Gum, Torque Wrench, Locator Core Tool
Tongue Scraper
Gutta Percha Points, Injectable Root Canal Sealer
Hand Driver, Lab hex Driver, Multi-Unit Hex Driver, Locator-Core Tool
Device Unit, Oral Irrigation
Dental scaler
Orthodontic wax
Dental Root Canal Instruments (Hand Files; Rotary files; Compactors; Enlargers; Paste Carrier; Barbed Broach)
Dental Burs (CARBIDE BURS, Dental Burs)
EDTA Root Canal Lubrication Gel
Hand Dental Pluggers
Abutment Screw, Multi-Unit Screw, Implant Analog, Impression Coping, Scan Body, Healing Cap, Hand Driver,
Lab hex Driver, Multi-Unit Hex Driver, Torque Wrench, Locator-Core Tool, Cover Cap
Orthodontic Wires (WIRE, ORTHODONTIC; Profa Wires)
Mouth Mirror
Absorbent Paper Points
Manual Toothbrush
Proxabrush/Proxy Brush; Soft Interdental Brush; Interdental Brush
Aligner Chewies
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)