FDA Registration
Active
🇨🇳 China
Long insertion handle
Reg #: 3026311512
·
FEI: 3026311512
·
Expires 2025
Products
1
Proprietary Names
13
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-01-04 |
Proprietary Names
Long insertion handle
Slap hammer
Slide hammer
Trial implant
Trocar 4 mm
Combined Hammer 500g
nerve root retractor
cup curettes
Cage inserter
Distractor
Bone graft funnel
Distractor 2
Trocar 3.2 mm
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)