FDA Registration
Active
🇨🇳 China
KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3011423165
·
FEI: 3011423165
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- KONTOUR (XI'AN) MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3011423165
- FEI Number
- 3011423165
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.1451, 1st Biyuan Road, High-tech District,
- City
- Xi'an Shaanxi
- Country
- CN
Owner / Operator
- Firm Name
- Kontour (Xi'an) Medical Technology Co., Ltd.
- Operator Number
- 10062728
- Address
- No.1451, 1st Biyuan Road, High-tech District,
- City
- Xi'an
- State
- Shaanxi
- Postal Code
- 710065
- Country
- CN
- Correspondent
- rongrong cong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Bone | JEY | Class 2 | Dental | No | 2020-03-12 |
| Plate, Cranioplasty, Preformed, Non-Alterable | GXN | Class 2 | Neurology | No | 2022-11-15 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2024-02-20 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2020-03-04 |
Proprietary Names
Modified Sterile Plate and Screw Configuration
Bioplate Rigid Fixation System
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Modified Screw Design
Disposable Screwdriver Blade
Modification to Bioplate Rigid Fixation System
BIOMESH
Sterile Plate and Screw Configuration
Titanuim Fixation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device