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
Phone
888 7681688

Products

Device Name Product Code
Tape, Measuring, Rulers And Calipers FTY
Instrument, Cranioplasty Material Forming HBX
Extractor HWB
Thoracolumbosacral Pedicle Screw System NKB
Awl HWJ
Starter, Bone Screw HWD
Wrench HXC
Pusher, Socket HXO
Screwdriver HXX
Impactor HWA
Bit, Drill HTW
Rasp HTR
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Rod, Fixation, Intramedullary And Accessories HSB
Template HWT
Tap, Bone HWX
Forceps, Wire Holding HYA
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Orthopedic Manual Surgical Instrument LXH
Cutter, Wire HXZ
Instrument, Manual, Surgical, General Use MDM
Rongeur HTX
Reamer HTO
Bender HXW

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)