Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013440400

FEI Number

3013440400

Entity Name

Micro-Tech (Nanjing) Co., Ltd.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

No. 199 Medicine Valley Avenue, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing Jiangsu 210032, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Micro-Tech (Nanjing) Co., Ltd. (Owner Number: 9067602)

Owner / Operator Contact Address

No.10, Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone, Nanjing, CN-JS 210032, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 SureFire 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) PB Digital Controller Visualized Access and Delivery Catheter eyeMAX slim Single-use Video Scope PB Digital Controller 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 Disposable Distal Cap 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) Disposable Inflation Device 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2018-10-22
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2018-10-22
NBG	Marker, Colon	Gastroenterology, Urology	Class 2	876.1500	2016-07-20
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2018-05-21
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2023-02-19
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2023-02-19
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-02-19
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-03-12
FDX	Endoscopic Cytology Brush	Gastroenterology, Urology	Class 2	876.1500	2018-03-05
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2019-06-03
MND	Ligator, Esophageal	Gastroenterology, Urology	Class 2	876.4400	2015-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-26
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-07-26
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2026-04-28
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2015-03-24
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2023-10-18
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2022-06-15
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-01-13
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2021-12-02
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2015-07-31
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-01-15
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2011-09-07
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	2018-05-15
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-06-06
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2018-12-18
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2026-02-23
QSW	Endoscopic Traction Device	Gastroenterology, Urology	Class 2	876.4410	2022-10-08
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-03-23
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2022-07-20
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2015-04-21
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2017-10-20
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2017-10-20
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	Class 2	876.1500	2016-03-02
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-28
SHU	Appendiceal Scope And Accessories, Flexible	Gastroenterology, Urology	Class 2	876.1500	2026-04-28
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2026-04-06
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-06
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-01-30
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-07-01
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2024-03-20
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-02-15
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2013-03-24
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2017-11-10
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2019-01-31
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2017-10-24
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2004-10-25
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2023-09-07
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2016-12-15
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2018-07-08
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2021-10-30
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-02-05
PLL	Submucosal Injection Agent	Gastroenterology, Urology	Class 2	876.1500	2020-11-05
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2024-09-23
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2017-01-08
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2021-12-07
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-12-07
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2026-01-16
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2022-03-29
KGE	Forceps, Biopsy, Electric	Gastroenterology, Urology	Class 2	876.4300	2021-03-16
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2013-04-03
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2015-06-03
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2022-07-06

Official Correspondent

Sally He

US Agent Details

Chris Li Email: ra.mtus@mtmed.com Phone: (877) 5524027

Related Public Records

Same Entity

Micro-Tech (Nanjing) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004837686	Micro-Tech (Nanjing) Co., Ltd.	NAN JING Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K902734	Olympus Corp.	PR CANNULAS	1990-08-22
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013440400. Last updated year: 2026. Please use registration number 3013440400 when referencing this establishment in official correspondence.