FDA Registration
Active
🇨🇳 China
ORTHGUIDE MEDICAL TECHNOLOGY (JIANGSU) CO., LTD
Reg #: 3034693059
·
FEI: 3034693059
·
Expires 2026
Products
17
Proprietary Names
2
Establishment Types
4
Classifications
17
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Registration Details
- Registration Name
- ORTHGUIDE MEDICAL TECHNOLOGY (JIANGSU) CO., LTD
- Registration Number
- 3034693059
- FEI Number
- 3034693059
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd Floor, Building D5, Life Science Park, Zone D, Huishan District, Wuxi City, Jiangsu Province
- City
- Wuxi City Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Orthguide Medical Technology (jiangsu) Co., Ltd
- Operator Number
- 10092062
- Address
- 3rd Floor, Building D5, Life Science Park, Zone D, Huishan District, Wuxi City, Jiangsu Province
- City
- Wuxi City
- State
- Jiangsu
- Postal Code
- 214174
- Country
- CN
- Correspondent
- Lanyan Li
US Agent
- Business Name
- Frank Zhuang
- Contact Name
- Frank Zhuang
- Address
- Chino, Ca 91710, Usa, 14586 Central Ave
- City
- Chino
- State
- CA
- ZIP
- 91710
- Country
- US
- [email protected]
- Phone
- 213 5597669
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2024-11-29 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2024-11-29 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2024-11-29 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2025-05-21 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2024-11-29 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2024-11-29 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2024-11-29 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2024-11-29 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2024-11-29 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2024-11-29 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2024-11-29 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2024-11-29 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2024-11-29 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-11-29 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2024-11-29 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2024-11-29 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2024-11-29 |
Proprietary Names
orthguide
orthguiede
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)