FDA Registration
Active
🇨🇳 China
ZHEJIANG EKSEN MEDICAL TECHNOLOGY CO., LTD
Reg #: 3015276158
·
FEI: 3015276158
·
Expires 2026
Products
9
Proprietary Names
11
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- ZHEJIANG EKSEN MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3015276158
- FEI Number
- 3015276158
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 1, 926 Changhong East Street, Fuxi Road, Deqing District
- City
- Huzhou Zhejiang
- Country
- CN
Owner / Operator
- Firm Name
- Zhejiang Eksen Medical Technology Co., Ltd
- Operator Number
- 10059984
- Address
- Building 1, 926 Changhong East Street, Fuxi Road, Deqing District
- City
- Huzhou
- State
- Zhejiang
- Postal Code
- 313200
- Country
- CN
- Correspondent
- Charles Shen
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 |
|---|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2019-03-18 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2019-03-18 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-05-21 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2019-03-18 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2019-03-18 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2019-03-18 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2019-03-18 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2019-03-18 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2019-03-18 |
Proprietary Names
Orthodontic Elastics
Orthodontic Hooks
Screw Expansion; Orthodontic Expansion Screws; Orthodontic Appliance
Root Canal Files
Orthodontic Wire
Orthodontic Tube
LeapBar Class III Malocclusion; Palatal Expander
Orthodontic Bracket; Lingual Button; LeapBar Class II Appliance; LeapBar Class II Corrector;
LeapBar Class II Malocclusion; Bite Corrector; LeapBar Class III Appliance; LeapBar Class III Corrector;
Orthodontic Plier
Orthodontic Band
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)