BEUDAMED
    FDA Registration Active 🇨🇳 China

    Micro-Tech (Nanjing) Co., Ltd.

    Reg #: 3004837686 · FEI: 3004837686 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    94
    Establishment Types
    2
    Classifications
    46

    Registration Details

    Registration Name
    Micro-Tech (Nanjing) Co., Ltd.
    Registration Number
    3004837686
    FEI Number
    3004837686
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.10 Gaoke Third Road,Nanjing National Hi-Tech Industrial Development Zone, Nanjing 210032,Jiangsu Province,PRC
    City
    NAN JING Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233772

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

    Proprietary Names

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

    Establishment Types

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