FDA Registration Active 🇨🇳 China

Micro-Tech (Nanjing) Co., Ltd.

Reg #: 3013440400 · FEI: 3013440400 · Expires 2026
Products
49
Proprietary Names
102
Establishment Types
3
Classifications
49

Registration Details

Registration Name
Micro-Tech (Nanjing) Co., Ltd.
Registration Number
3013440400
FEI Number
3013440400
Status
Active
Expiry Year
2026
Initial Importer
No
Address
No. 199 Medicine Valley Avenue, Nanjing National Hi-Tech, Industrial Development Zone
City
Nanjing Jiangsu
Country
CN

Regulatory Submissions

510(k) Number
K180418

Owner / Operator

Firm Name
Micro-Tech (Nanjing) Co., Ltd.
Operator Number
9067602
Address
No.10, Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone
City
Nanjing
State
Jiangsu
Postal Code
210032
Country
CN
Correspondent
Sally - He

Products

Device Name Product Code
Dilator, Esophageal KNQ
Stents, Drains And Dilators For The Biliary Ducts FGE
Marker, Colon NBG
Prosthesis, Esophageal ESW
Led Light Source NTN
Camera, Surgical And Accessories KQM
Choledochoscope And Accessories, Flexible/Rigid FBN
Snare, Surgical GAE
Endoscopic Cytology Brush FDX
Ligator, Esophageal MND
Electrosurgical, Cutting & Coagulation & Accessories GEI
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Ligator, Hemorrhoidal FHN
Needle, Tumor Localization MIJ
Hemostatic Metal Clip For The Gi Tract PKL
Instrument, Manual, Surgical, General Use MDM
Snare, Flexible FDI
Endoscopic Ultrasound System, Gastroenterology-Urology ODG
Accessories, Cleaning Brushes, For Endoscope MNL
Adaptor, Catheter GCE
Endoscopic Traction Device QSW
Bronchoscope Accessory KTI
Biopsy Needle FCG
Endoscopic Grasping/Cutting Instrument, Non-Powered OCZ
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Appendiceal Scope And Accessories, Flexible SHU
Instrument, Biopsy KNW
Gastroscope And Accessories, Flexible/Rigid FDS
Endoscopic Guidewire, Gastroenterology-Urology OCY
Snare, Non-Electrical FGX
Syringe, Balloon Inflation, Exempt PTM
Tape, Measuring, Rulers And Calipers FTY
Bedding, Disposable, Medical KME
Forceps, Biopsy, Non-Electric FCL
System, Imaging, Optical Coherence Tomography (Oct) NQQ
Forceps, Biopsy, Electric KGE
Prosthesis, Tracheal, Expandable JCT
Lavage, Jet FQH
Submucosal Injection Agent PLL
System, Ablation, Microwave And Accessories NEY
Guide, Surgical, Instrument FZX
Endoscope Channel Accessory ODC
Bottle, Collection, Vacuum KDQ
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
Bronchoscope (Flexible Or Rigid) EOQ
Dislodger, Stone, Biliary LQR
Endoscopic Access Overtube, Gastroenterology-Urology FED
Endoscopic Bite Block MNK

Proprietary Names

Reliant(TM) Multistage Dilatation Balloon Catheter Blue Beacon(TM) GI Marker EndoINK(TM) Endoscopic Marker STA-BIL(TM) Non-migrating Endoscopic Ink Esophageal Stent System PB Digital Controller Single-use Video Pancreaticobiliary Scope LesionHunter™ Rotatable Nitinol Cold Snare Cold Snare Cytology Brush Segmented Esophageal Stent System SureFire™ Multiple Band Ligator Set Multiple Band Ligator Set Single Use Electrosurgical Knife Dilation Balloon Catheter Hemorrhoid Multiple Band Ligator Set Mammo-Flex Quad-Flex Localization System S.T.A.R (TM) Disposable Hemostatic Closure Clip Device Pulmonary Hydro-Slide Guidewire Sterile Sphincterotome Sphincterotome / short-wire compatible Polypectomy Snare EdgeHog(TM) Polypectomy Snare Ultrasound Disposable Kits Disposable Cleaning Brush Disposable Dilator Brush Spray Catheter Single Use MultiClip Device SureClip(R) Repositionable Hemostasis Clip CAPTurator™ Advanced Tissue Resection Device SureTrac(TM) Elastic Traction System Disposable Distal Cap Areus™ Endobronchial Ultrasound Aspiration Needle Trident™ Endobronchial Ultrasound Aspiration Needle Disposable Dilation Balloon Rapide™ Multistage Dilatation Balloon Catheter ABC Dilatation Balloon Catheter OnScope(TM) Endoscopic Dilator Kit Areus™ Endoscopic Ultrasound Aspiration Needle(FNA) Trident™ Endoscopic Ultrasound Biopsy Needle(FNB) Visualized Access and Delivery Catheter eyeMAX slim Single-use Video Scope M Biopsy Automatic Disposable Biopsy Needle M Biopsy Coaxial Biopsy Needle M Biopsy Semi-automatic Disposable Biopsy Needle SureCore Automatic Disposable Biopsy Needle SureCore Semi-automatic Disposable Biopsy Needle SureAim Coaxial Biopsy Needle Visor Cap™ Disposable Distal Cap Disposable Dual Action Tissue Closure Device Sterile Hydro-Slide Guidewire Single-Use Marked Spring Tip Guidewire SpiraTrax™ Sterile Hydro-Slide Guidewire EnTrap(TM) Polyp Retrieval Snare Net Disposable Inflation Device Insuflator Pump Napoleon(TM) Endoscopic Polyp Measurement Device CatchAll(TM) Transport Pad Single-Use Biopsy Forceps Precisor Disposable Biopsy Forceps (Transferred from CONMED CORPORATION) Jumbo Single-use Biopsy Forceps OptiBite Disposable Biopsy Forceps Biliary Plastic Stent Set/ short-wire compatible Biliary Plastic Stent Set Biliary Plastic Stent Biliary Plastic Stent Introducer/ short-wire compatible Biliary Plastic Stent Introducer LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-18-55-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-16-30-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-20-80-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-20-55-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-18-80-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-20-30-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-16-80-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-16-55-25-7 LuminScanTM Imaging System Console-EOCT-C1-10-10-Disposable Imaging Kit-BOP-18-30-25-7 Disposable Hot Biopsy Forceps Tracheal Stent System (Y-Shaped) BlueBoost(TM) Submucosal Injectable Solution Microwave Ablation Antennas RiteClip(TM) Repositionable Hemostasis Clip Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle Trident (TM) Adapt Endoscopic Ultrasound Biopsy Needle Additional Working Channel Guidewire Locking Device Ensure(TM) Single-Use Coagulation Forceps Polyp Collection Kit Injection Needle Pinpoint Injection Needle Grasping Forceps Through the Scope Tracheal Stent System Single-Use Video Bronchoscope Digital Controller Fluid Pump System Lockado(TM) Repositionable Hemostasis Clip Extraction Basket Tracheal Stent System (OTW) Embrella(TM) Endoscopic Distal Attachment Retrieval Balloon / short-wire compatible Sterile Biliary Stone Retrieval Balloon Catheter Dual Action Tissue Closure Device (DAT™ Slim) Disposble Bite Block

Establishment Types

Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)