FDA Registration
Active
🇨🇳 China
Ultrasonic Osteotomy Surgical System
Reg #: 3021599290
·
FEI: 3021599290
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMTP MEDICAL CO., LTD.
- Registration Number
- 3021599290
- FEI Number
- 3021599290
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 2301 of Sector C and Room 2301 of Sector D, Building 1, No.29 Qingfeng West Road, Daxing Bio-medicine Industry Park
- City
- Daxing District Beijing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201274
Owner / Operator
- Firm Name
- SMTP Medical Co., Ltd.
- Operator Number
- 10083856
- Address
- No.29 Qingfeng West Road, Daxing Bio-medicine Industry Park, Room 2301, Sector D, Building 1
- City
- Daxing District
- State
- Beijing
- Postal Code
- 102629
- Country
- CN
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2021-12-23 |
Proprietary Names
Ultrasonic Osteotomy Surgical System
Establishment Types
Manufacture Medical Device