Micro-Tech (Nanjing) Co., Ltd.
Manufacturer and brand owner in Nan Jing, Jiangsu, China. 49 device types, 96 products catalogued, 41 clearances.
Micro-Tech (Nanjing) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Lavage, Jet, Biopsy Needle and 47 other device types. 94 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2004.
49device types registered with the FDA
96products catalogued under its own name
41510(k) clearances
3recalls
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3004837686 |
| FEI number | 3004837686 |
| DUNS | 530269083 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 南微医学科技股份有限公司 |
|---|---|
| Source | EMIS company database |
Location
| City | Nan Jing |
|---|---|
| Province | Jiangsu |
| Address | NO.10 Gaoke Third Road,Nanjing National Hi-Tech Industrial Development Zone |
| Postal code | 210032 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | Class 1 | Disposable Cleaning Brush, Disposable Dilator Brush | 2011 | 43 |
| Adaptor, Catheter | Class 1 | Spray Catheter | 2018 | 4 |
| Appendiceal Scope And Accessories, Flexible | Class 2 | Visualized Access and Delivery Catheter (eyeMAX™), PB Digital Controller | 2026 | 1 |
| Bedding, Disposable, Medical | Class 1 | CatchAll™ Transport Pad | 2017 | 308 |
| Biopsy Needle | Class 2 | Areus™ Adapt Endoscopic Ultrasound Aspiration Needle, Trident™ Adapt Endoscopic Ultrasound Biopsy Needle, Trident™ Endoscopic Ultrasound Biopsy Needle(FNB), Areus™ Endoscopic Ultrasound Aspiration Needle(FNA) | 2017 | 3 |
| Bottle, Collection, Vacuum | Class 2 | Polyp Collection Kit | 2013 | 88 |
| Bronchoscope (Flexible Or Rigid) | Class 2 | Single-Use Video Bronchoscope, Digital Controller | 2022 | 21 |
| Bronchoscope Accessory | Class 2 | Trident™ Endobronchial Ultrasound Aspiration Needle, Areus™ Endobronchial Ultrasound Aspiration Needle | 2022 | 5 |
| Camera, Surgical And Accessories | Class 1 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | 2023 | 22 |
| Choledochoscope And Accessories, Flexible/Rigid | Class 2 | Disposable Distal Cap (eyeMAX™), Single-use Video Pancreaticobiliary Scope, PB Digital Controller, eyeMAX slim Single-use Video Scope | 2023 | 8 |
| Dilator, Esophageal | Class 2 | Reliant™ Multistage Dilatation Balloon Catheter, Disposable Dilation Balloon, ABC Dilatation Balloon Catheter, OnScope™ Endoscopic Dilator Kit | 2015 | 9 |
| Dislodger, Stone, Biliary | Class 2 | Extraction Basket (eyeMAX™), Extraction Basket | 2024 | 5 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Fluid Pump System, Single Use Electrosurgical Knife | 2020 | 65 |
| Endoscope Channel Accessory | Class 2 | Guidewire Locking Device | 2022 | 21 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | Embrella™ Endoscopic Distal Attachment | 2019 | 19 |
| Endoscopic Bite Block | Class 1 | Disposble Bite Block | 2012 | 44 |
| Endoscopic Cytology Brush | Class 2 | Cytology Brush | 2018 | 5 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Class 2 | 2016 | 6 | |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Grasping Forceps | 2022 | 21 |
| Endoscopic Guidewire, Gastroenterology-Urology | Class 2 | Sterile Hydro-Slide Guidewire, Single-Use Marked Spring Tip Guidewire, SpiraTrax™ Sterile Hydro-Slide Guidewire | 2019 | 21 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | Injection Needle, Pinpoint™ Injection Needle | 2015 | 23 |
| Endoscopic Traction Device | Class 2 | SureTrac™ Elastic Traction System | 2022 | 1 |
| Endoscopic Ultrasound System, Gastroenterology-Urology | Class 2 | Areus™ Adapt Endoscopic Ultrasound Aspiration Needle, Trident™ Adapt Endoscopic Ultrasound Biopsy Needle, Ultrasound Disposable Kits, Trident™ Endoscopic Ultrasound Biopsy Needle(FNB), Areus™ Endoscopic Ultrasound Aspiration Needle(FNA) | 2017 | 1 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class 2 | PB Digital Controller, eyeMAX slim Single-use Video Scope, Visualized Access and Delivery Catheter (eyeMAX™) | 2026 | 8 |
| Forceps, Biopsy, Electric | Class 2 | Ensure(TM) Single-Use Coagulation Forceps, Ensure™ Single-Use Coagulation Forceps, Disposable Hot Biopsy Forceps | 2018 | 3 |
| Forceps, Biopsy, Non-Electric | Class 1 | Single-Use Biopsy Forceps (eyeMAX™), Single-Use Biopsy Forceps, OptiBite Disposable Biopsy Forceps, Jumbo Single-use Biopsy Forceps, Precisor(R) Disposable Biopsy Forceps (Transferred from CONMED CORPORATION) | 2004 | 44 |
| Gastroscope And Accessories, Flexible/Rigid | Class 2 | Visor Cap™ Disposable Distal Cap, Disposable Distal Cap | 2025 | 9 |
| Guide, Surgical, Instrument | Class 1 | Additional Working Channel | 2026 | 26 |
| Hemostatic Metal Clip For The Gi Tract | Class 2 | Disposable Dual Action Tissue Closure Device, Single Use MultiClip Device, Dual Action Tissue Closure Device (DAT™ Slim), RiteClip™ Repositionable Hemostasis Clip, SureClip(R) Repositionable Hemostasis Clip, Lockado™ Repositionable Hemostasis Clip and 1 more | 2017 | 17 |
| Instrument, Biopsy | Class 2 | M Biopsy Automatic Disposable Biopsy Needle, M Biopsy Coaxial Biopsy Needle, M Biopsy Semi-automatic Disposable Biopsy Needle, SureCore Semi-automatic Disposable Biopsy Needle, SureCore Automatic Disposable Biopsy Needle, SureAim Coaxial Biopsy Needle | 2024 | 9 |
| Instrument, Manual, Surgical, General Use | Class 1 | Pulmonary Hydro-Slide Guidewire | 2026 | 110 |
| Lavage, Jet | Class 2 | Fluid Pump System, Single Use Electrosurgical Knife, Disposable Inflation Device | 2021 | 17 |
| Led Light Source | Class 2 | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | 2023 | 11 |
| Ligator, Esophageal | Class 2 | Multiple Band Ligator Set, SureFire™ Multiple Band Ligator Set | 2015 | 7 |
| Ligator, Hemorrhoidal | Class 2 | Hemorrhoid Multiple Band Ligator Set, SureFire™ Multiple Band Ligator Set | 2015 | 12 |
| Marker, Colon | Class 2 | Blue Beacon™ GI Marker, EndoINK™ Endoscopic Marker, STA-BIL™ Non-migrating Endoscopic Ink | 2016 | 1 |
| Needle, Tumor Localization | Class 1 | Mammo-Flex Quad-Flex Localization System | 2023 | 3 |
| Prosthesis, Esophageal | Class 2 | Segmented Esophageal Stent System, Esophageal Stent System | 2018 | 1 |
| Prosthesis, Tracheal, Expandable | Class 2 | Tracheal Stent System (OTW), Tracheal Stent System (Y-Shaped), Through the Scope Tracheal Stent System | 2021 | 1 |
| Snare, Flexible | Class 2 | CAPTurator™ Advanced Tissue Resection Device, EdgeHog™ Polypectomy Snare, Polypectomy Snare, ADVANTIS™ Polypectomy Snare | 2015 | 7 |
| Snare, Non-Electrical | Class 1 | EnTrap™ Polyp Retrieval Snare Net | 2013 | 19 |
| Snare, Surgical | Class 1 | Cold Snare, LesionHunter™ Rotatable Nitinol Cold Snare | 2015 | 9 |
| Stents, Drains And Dilators For The Biliary Ducts | Class 2 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible, Dilation Balloon Catheter (eyeMAX™), Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible and 3 more | 2018 | 6 |
| Submucosal Injection Agent | Class 2 | BlueBoost™ Submucosal Injectable Solution | 2020 | 3 |
| Syringe, Balloon Inflation, Exempt | Class 2 | Disposable Inflation Device, Insuflator Pump | 2017 | 16 |
| System, Ablation, Microwave And Accessories | Class 2 | Microwave Ablation Antennas | 2024 | 10 |
| System, Imaging, Optical Coherence Tomography (Oct) | Class 2 | 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-18-80-25-7, 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-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-20-30-25-7 and 3 more | 2016 | 2 |
| Tape, Measuring, Rulers And Calipers | Class 1 | Napoleon™ Endoscopic Polyp Measurement Device | 2019 | 42 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class 2 | Single Use Electrosurgical Knife, Sphincterotome / short-wire compatible, Sterile Sphincterotome | 2020 | 7 |
Own-Brand Listings
Clearances
41 clearances name Micro-Tech (Nanjing) Co., Ltd. as applicant. 6 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252492 | 2026-04-24 | SHU | Traditional | This company |
| K251692 | 2026-02-21 | FDI | Traditional | This company |
| K250229 | 2025-09-08 | PKL | Traditional | This company |
| K243388 | 2025-06-27 | FDS | Traditional | This company |
| K243471 | 2024-12-16 | LQR | Traditional | This company |
| K230127 | 2023-09-06 | FGE | Traditional | This company |
| K221784 | 2023-02-16 | FBN | Traditional | This company |
| K222354 | 2022-10-03 | QSW | Traditional | This company |
| K213060 | 2022-07-20 | KTI | Traditional | This company |
| K220424 | 2022-07-08 | JCT | Traditional | This company |
| K220157 | 2022-06-13 | PKL | Traditional | This company |
| K211021 | 2022-05-06 | FGE | Traditional | This company |
| K220247 | 2022-03-29 | ODC | Traditional | This company |
| K212748 | 2022-01-20 | PKL | Traditional | This company |
| K211172 | 2021-12-17 | GEI | Traditional | This company |
| K212852 | 2021-12-06 | ODG | Traditional | This company |
| K210934 | 2021-12-01 | KNS | Traditional | This company |
| K212403 | 2021-10-30 | JCT | Traditional | This company |
| K202204 | 2021-09-01 | JCT | Traditional | This company |
| K202438 | 2021-03-15 | KGE | Traditional | This company |
| K202333 | 2021-01-14 | PKL | Traditional | This company |
| K200071 | 2020-11-03 | PLL | Traditional | This company |
| K193601 | 2020-07-24 | GEI | Traditional | This company |
| K182910 | 2019-05-29 | ESW | Traditional | This company |
| K190030 | 2019-03-05 | FED | Traditional | This company |
| K182556 | 2018-12-14 | PKL | Traditional | This company |
| K180418 | 2018-10-15 | FGE | Traditional | This company |
| K180018 | 2018-07-05 | KGE | Traditional | This company |
| K180325 | 2018-06-01 | PKL | Traditional | This company |
| K172813 | 2018-05-18 | ESW | Traditional | This company |
| K172663 | 2018-03-05 | FDX | Traditional | This company |
| K172309 | 2017-09-29 | ODG | Traditional | This company |
| K162226 | 2017-01-25 | FGE | Traditional | This company |
| K161463 | 2017-01-06 | PKL | Traditional | This company |
| K162466 | 2016-11-29 | NQQ | Traditional | This company |
| K160625 | 2016-06-14 | KGE | Traditional | This company |
| K152802 | 2016-01-21 | OCZ | Traditional | This company |
| K152001 | 2015-12-10 | PKL | Traditional | This company |
| K151671 | 2015-10-16 | FGE | Traditional | This company |
| K150316 | 2015-07-30 | FDI | Traditional | This company |
| K150434 | 2015-06-02 | FBK | Traditional | This company |
| K260262 | 2026-05-29 | FBK | Traditional | Mirco-Tech (Nanjing) Co., Ltd. |
| K253832 | 2026-04-24 | FGE | Traditional | Mirco-Tech (Nanjing) Co., Ltd. |
| K254153 | 2026-04-03 | FBN | Traditional | Mirco-Tech (Nanjing) Co., Ltd. |
| K253139 | 2026-03-19 | FBN | Traditional | Mirco-Tech (Nanjing) Co., Ltd. |
| K233772 | 2024-03-19 | PKL | Traditional | Mirco-Tech (Nanjing) Co., Ltd. |
| K213782 | 2022-07-08 | EOQ | Traditional | Micro-Tech (Nanjing) Co., Lts |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-09-20 | Class II | Under Investigation by firm | Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units | 1360 pcs | 2019-10-21 |
| 2018-03-12 | Class II | Device Design | The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury. | 40 total | 2018-08-30 |
| 2018-03-12 | Class II | Device Design | The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury. | 40 total | 2018-08-30 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | digestive endoscopy tools, radiological intervention devices, surgical instruments, electric snares |
|---|---|
| Export markets | over 70 countries |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.