FDA Registration
Active
🇨🇳 China
Drill Bit 4.5mm
Reg #: 3026311512
·
FEI: 3026311512
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
- Registration Number
- 3026311512
- FEI Number
- 3026311512
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Changzhou Geasure Medical Apparatus and Instruments Co., Ltd
- Operator Number
- 10086983
- Address
- No. 12, Jinfeng Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213149
- Country
- CN
- Correspondent
- Jing Huang
US Agent
- Business Name
- PUREVISION AI, INC.
- Contact Name
- DJ Fang
- Address
- 111 Town Square Place, Suite 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 201 5035758
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-08-21 |
Proprietary Names
Drill Bit 4.5mm
Universal Drill Guide 2.5 to 3.5
Drill Sleeve 8/4
LCP Drill Sleeve 2.7 for Drill Bits 2mm
Drill Sleeve 7.2
LCP Drill Sleeve 3.5, for Drill Bits 2.8 mm
Drill Bit 2.5 mm
Drill Bit 4.3 mm
Drill Sleeve 2
Drill Bit 2 mm
Drill Bit 11 mm
Protection Sleeve 20/17
centering sleeve
Protection Sleeve 11/8
Drill Sleeve 20/17
Universal Drill Guide 2 to 4
Drill Bit 4mm
Drill Sleeve 4.2
universal drill Guide 3.2-4.5
LCP Drill Sleeve 2.4 for Drill Bits 1.8mm
Drill Bit 1.5mm
Drill Bits 1.8mm
Drill Bit 3.2
Fixation Sleeve
Drill Bit 16.5mm
LCP Drill Bit 2.8mm
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)