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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2018-10-22 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2018-10-22 |
| Marker, Colon | NBG | Class 2 | Gastroenterology, Urology | No | 2016-07-20 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2018-05-21 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2023-02-19 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2023-02-19 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2023-02-19 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2015-03-12 |
| Endoscopic Cytology Brush | FDX | Class 2 | Gastroenterology, Urology | No | 2018-03-05 |
| Ligator, Esophageal | MND | Class 2 | Gastroenterology, Urology | No | 2015-12-17 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-07-26 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2020-07-26 |
| Ligator, Hemorrhoidal | FHN | Class 2 | Gastroenterology, Urology | No | 2015-03-24 |
| Needle, Tumor Localization | MIJ | Class 1 | General, Plastic Surgery | No | 2023-10-18 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2022-06-15 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2026-01-13 |
| Snare, Flexible | FDI | Class 2 | Gastroenterology, Urology | No | 2015-07-31 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | Class 2 | Gastroenterology, Urology | No | 2024-01-15 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2011-09-07 |
| Adaptor, Catheter | GCE | Class 1 | General, Plastic Surgery | No | 2018-05-15 |
| Endoscopic Traction Device | QSW | Class 2 | Gastroenterology, Urology | No | 2022-10-08 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2022-07-20 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2017-10-20 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | Class 2 | Gastroenterology, Urology | No | 2016-03-02 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2026-04-28 |
| Appendiceal Scope And Accessories, Flexible | SHU | Class 2 | Gastroenterology, Urology | No | 2026-04-28 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2024-01-30 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | Class 2 | Gastroenterology, Urology | No | 2025-07-01 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2019-02-15 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2013-03-24 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2017-11-10 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2019-01-31 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2017-10-24 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2004-10-25 |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2016-12-15 |
| Forceps, Biopsy, Electric | KGE | Class 2 | Gastroenterology, Urology | No | 2018-07-08 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2021-10-30 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2025-02-05 |
| Submucosal Injection Agent | PLL | Class 2 | Gastroenterology, Urology | No | 2020-11-05 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2024-09-23 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-01-16 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2022-03-29 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2013-04-03 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2015-06-03 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2022-07-06 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2022-07-08 |
| Dislodger, Stone, Biliary | LQR | Class 2 | Gastroenterology, Urology | No | 2024-12-19 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2019-03-07 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2012-08-26 |
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)