FDA Registration
Active
🇨🇳 China
Steerable Bone Cement Filler Device, S13-05, S13-03
Reg #: 3035858921
·
FEI: 3035858921
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHANGHAI LANGE MEDTECH CO., LTD.
- Registration Number
- 3035858921
- FEI Number
- 3035858921
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1st floor, Building 22, 1500 Duhui Road, Minhang District
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai Lange Medtech Co., Ltd.
- Operator Number
- 10092484
- Address
- 1st floor, Building 22, 1500 Duhui Road, Minhang District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201108
- Country
- CN
- Correspondent
- Xin Zhou
US Agent
- Business Name
- Humiss Inc.
- Contact Name
- James St. Wu
- Address
- 1942 Broadway Ste 314c
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7595888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2025-01-14 |
Proprietary Names
Steerable Bone Cement Filler Device, S13-05, S13-03
Bone Cement Filler Device, S03-01, S03-02, S03-03, S03-04
Bone Cement Application Kit, S02-10, S02-101, S12-20, S12-201
Establishment Types
Manufacture Medical Device