FDA Registration
Active
🇨🇳 China
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
Reg #: 3026311512
·
FEI: 3026311512
·
Expires 2026
Products
25
Proprietary Names
131
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
- Registration Number
- 3026311512
- FEI Number
- 3026311512
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.12 Jinfeng Road, West Taihu Science and Technology Industrial Park
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222031
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. (DBA PURE GLOBAL)
- Contact Name
- Bryan Wong
- Address
- 111 Town Square Pl Ste 1203
- City
- Jersey City
- State
- NJ
- ZIP
- 07310
- Country
- US
- [email protected]
- Phone
- 888 7681688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-01-04 |
| Instrument, Cranioplasty Material Forming | HBX | Class 1 | Neurology | No | 2023-01-04 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2023-01-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-12-29 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2023-01-04 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2023-01-04 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-01-04 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2023-01-04 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2023-01-04 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2023-01-04 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-08-21 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2023-01-04 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-12-21 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2023-12-21 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-08-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2023-01-04 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2023-01-04 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2023-01-04 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-05-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-01-04 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2023-01-04 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2023-01-04 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2023-01-04 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-01-04 |
| Bender | HXW | Class 1 | Orthopedic | No | 2023-01-04 |
Proprietary Names
Measuring Credit Card
Measuring Device for Locking Bolt
Measuring Block
2 Depth Gauge
Depth Gauge for Screws 2.4 to 2.7mm, measuring range up to 40mm
Depth Gauge for Screws 2.7 to 4mm, measuring range up to 60 mm
Radiographic Ruler
Direct Measuring Device for Guide Wire
Length probe
Dual Ended Feeler Probe, Sensor,Single Head
Distractor, size 7-14
Spinal Inner Fixation System
Awl, ?3.2, Probe,Straight, ?3.5, Probe,Curved
paddle starter
Rod Rotated Wrench,SW4
Pin Wrench 4.5 mm
Rod Pusher ?5.5
Ratcheting Handle,Quick Connect, T-Handle Ratcheting ,Quick Connect, Multi Axial Reduction Screwdriver
Torque Limiter, 0.8Nm
Extraction Screw for screws 2 and 2.4mm
Screwdriver Shaft 3.5, hexagonal
Screwdriver, hexagonal with spherical head 10 mm, cannulated
Torque Limiter 4N
Screw tap HA4.5
Fixed Angle Screwdriver, Crosslink Setscrew Driver,SW3.5
Screwdriver Shaft,hexagonal, small, 2.5mm
Handle with Quick Coupling
Stardriver
Torque-Limiting Handle,12.5N.m
Self-Retaining Break-Off Driver
Extraction Screw for Screws 3.5mm
Multi Axial Screwdriver, Fixed Angle Reduction Screwdriver
Torque Limiter, 1.5Nm
Self-Retaining Set Screw Driver
Dual Ended Plug Starter, T-Handle with Quick Connect
Universal Chuck with T-Handle
Short Screw driver With Retention Hex (3.5mm) (B)
Handle for Torque Limiters 0.4/0.8/1.2Nm
hexagonal screwdriver
Handle for Torque Limiter
Extraction Screw, conical, for Screws 1.5 and 2mm
Extraction Screw, conical, for Screws 2.7, 3.5, 4 and 4.5
Screw tap HB 6.5
Insertion Handle
torque-limiting screwdriver
Screwdriver, hexagonal, large, 3.5 mm
Flexible Hex Driver Ball Tip (5mm/8mm) (B)
impactor
Universal Drill Guide 2.5 to 3.5
LCP Drill Sleeve 2.4 for Drill Bits 1.8mm
Drill Bits 1.8mm
Drill Bit 3.2
centering sleeve
LCP Drill Sleeve 2.7 for Drill Bits 2mm
Drill Sleeve 20/17
Universal Drill Guide 2 to 4
Drill Bit 4mm
Drill Bit 2.5 mm
Drill Sleeve 2
Drill Bit 4.5mm
Protection Sleeve 20/17
Drill Bit 11 mm
Fixation Sleeve
LCP Drill Bit 2.8mm
Drill Bit 16.5mm
Drill Bit 1.5mm
Drill Sleeve 4.2
LCP Drill Sleeve 3.5, for Drill Bits 2.8 mm
Drill Bit 4.3 mm
Drill Sleeve 8/4
Drill Sleeve 7.2
Drill Bit 2 mm
Protection Sleeve 11/8
universal drill Guide 3.2-4.5
Osteotome
Rasp
Internal Locking Plate and Screw Fixation System
SGM Femoral Nail System
Rod Template,200mm, Rod Template,500mm
Tap,4.5, Tap,5.5, Tap,6.5, Tap,7.5
rotate cutter 14
rotate cutter 8
rotate cutter 11
rotate cutter 10
rotate cutter 12
rotate cutter 9
Beale Rod Reducer
plate holding forceps
Rod Holder
Reduction Forceps
Instrument for temporary reduction
Plate Holder with Thread
pointed reduction forceps
Rod Reducer
PEEK Spinal Fusion Cage
cup curettes
Bone graft funnel
Slide hammer
Trial implant
nerve root retractor
Trocar 3.2 mm
Combined Hammer 500g
Distractor 2
Slap hammer
Trocar 4 mm
Distractor
Cage inserter
Long insertion handle
Rod Cutter
Kirschner wires 1.5
Kirschner wires 0.8
Guide Wire 3.2 mm
Kirschner wires 2
Guide Wire 2.8 mm
Tube,14mm
Tube,7mm
Rod Inserter ?5.5
pituitary rongeur
Opening Reamer 14mm
Shaver
Opening Reamer 13mm
Rod Bender
In-Situ Benders ?5.5,Right
Plate Bender
Bending Pliers for Reconstruction Plates 3.5
In-Situ Benders ?5.5,Left
Coronal Benders, Right
Bending Iron for Reconstruction Plates 3.5 and 4.5
Bending/Cutting Pliers
Bending Pliers for Plates 2.4 to 4
Coronal Benders, Left
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)