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Mirco-Tech (Nanjing) Co., Ltd.

China·CN-MF-000006950

Last updated May 23, 2026

What Mirco-Tech (Nanjing) Co., Ltd. makes

Mirco-Tech (Nanjing) Co., Ltd. manufactures medical devices including dilation balloon catheters for vascular procedures, single-use video scopes paired with digital controllers for endoscopic imaging, disposable distal caps for catheter protection, and disposable dual-action tissue closure devices for wound management.

The company’s portfolio consists of Class II devices, all of which are listed via FDA 510(k) clearance. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Mirco-Tech (Nanjing) Co., Ltd. manufacture?

Mirco-Tech (Nanjing) Co., Ltd. specializes in Class II medical devices, including dilation balloon catheters for vascular procedures, single-use video scopes paired with digital controllers for endoscopic imaging, disposable distal caps for catheter protection, and disposable dual-action tissue closure devices for wound management. These devices are designed for specific clinical applications like vascular interventions, endoscopy, and wound care.

Where is Mirco-Tech (Nanjing) Co., Ltd. based?

Mirco-Tech (Nanjing) Co., Ltd. is headquartered in the United States. The company’s location in the US aligns with regulatory requirements for manufacturing and distribution of medical devices in North America.

Which regulatory registries or databases list Mirco-Tech’s devices?

Mirco-Tech’s devices are listed in the FDA’s 510(k) clearance registry. This means each product has undergone a premarket submission process to demonstrate substantial equivalence to a legally marketed predicate device, allowing it to enter the US market under FDA regulations.

How are Mirco-Tech’s devices classified under medical device regulations?

All of Mirco-Tech’s devices fall under Class II classification. This classification is assigned based on the risk level of the device—Class II devices pose moderate risk and require special controls (like performance standards or post-market surveillance) to ensure safety and effectiveness, in addition to general controls.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
China
Address
No.10, Gaoke Third Road, Nanjing National Hi-Tech Industrial Development Zone, Nanjing, China
Website
www.micro-tech-medical.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+86-25-58609879/58646393
PRRC Contact
Becky Li
EUDAMED SRN
CN-MF-000006950
FDA FEI Number
—
DUNS Number
—

Catalogue (1445)

Page 29 of 29
DeviceModel / ReferenceRegistriesClassStatus
Single Use Electrosurgical Knife K193601
FDA 510(k)
Class IIActive
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible K230127
FDA 510(k)
Class IIActive
Grasping Forceps K152802
EUDAMEDFDA 510(k)
Class IIActive
Advanced Tissue Resection Device K251692
FDA 510(k)
Class IIActive
Reliant Multistage Dilatation Balloon Catheter K162226
FDA 510(k)
Class IIActive
Disposable Hot Biopsy Forceps K160625
FDA 510(k)
Class IIActive
Single Use Electrosurgical Knife with Fluid Pump System K211172
EUDAMEDFDA 510(k)
Class IIActive
Esophageal Stent System K172813
FDA 510(k)
Class IIActive
Disposable Multistage Dilation Balloon Catheter K151671
EUDAMEDFDA 510(k)
Class IIActive
Tracheal Stent System K202204
FDA 510(k)
Class IIActive
Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible K211021
FDA 510(k)
Class IIActive
Sterile Repositionable Hemostasis Clipping Device K152001
FDA 510(k)
Class IIActive
Dilation Balloon Catheter K253832
FDA 510(k)
Class IIActive
Ensure Single-Use Coagulation Forceps K202438
FDA 510(k)
Class IIActive
Disposable Dual Action Tissue Clip K212748
FDA 510(k)
Class IIActive
Single-use Video Scope; PB Digital Controller K254153
FDA 510(k)
Class IIActive
Tracheal Stent System (Y-Shaped) K212403
FDA 510(k)
Class IIActive
Dual Action Tissue Closure Device K250229
FDA 510(k)
Class IIActive
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle K212852
FDA 510(k)
Class IIActive
SureClip Repositionable Hemostasis Clip K182556
FDA 510(k)
Class IIActive
Sphincterotome / short-wire compatible, Sterile Sphincterotome K210934
FDA 510(k)
Class IIActive
Disposable Distal Cap K253139
FDA 510(k)
Class IIActive
Reliant(TM) Multistage Dilatation Balloon Catheter K180418
FDA 510(k)
Class IIActive
Single Use MultiClip Device K180325
FDA 510(k)
Class IIActive
LuminScan (TM) Imaging System K162466
FDA 510(k)
Class IIActive
Disposable Hot Biopsy Forceps K180018
FDA 510(k)
Class IIActive
Polypectomy Snare K150316
FDA 510(k)
Class IIActive
Segmented Esophageal Stent System K182910
FDA 510(k)
Class IIActive
Extraction Basket K243471
FDA 510(k)
Class IIActive
Lockado Repositionable Hemostasis Clip K202333
FDA 510(k)
Class IIActive
Injection Needle K150434
FDA 510(k)
Class IIActive
Cytology Brush K172663
FDA 510(k)
Class IIActive
Guidewire Locking Device K220247
FDA 510(k)
Class IIActive
Disposable Hemostatic Closure Clip Device K220157
FDA 510(k)
Class IIActive
Through the Scope Tracheal Stent System K220424
FDA 510(k)
Class IIActive
Visualized Access and Delivery Catheter; PB Digital Controller K252492
EUDAMEDFDA 510(k)
Class IIActive
Blue Beacon Submucosal Injectable Solution K200071
FDA 510(k)
Class IIActive
Disposable Dual Action Tissue Closure Device K233772
FDA 510(k)
Class IIActive
SureClip(TM) Repositionable Hemostasis Clip K161463
FDA 510(k)
Class IIActive
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle K213060
FDA 510(k)
Class IIActive
Endoscopic Ultrasound Aspiration Needle EUS-22-1
EUDAMED
Class IIaActive
Endoscopic Ultrasound Aspiration Needle EUS-25-1-N
EUDAMED
Class IIaActive
Endoscopic Ultrasound Aspiration Needle EUS-19-1
EUDAMED
Class IIaActive
Endoscopic Ultrasound Aspiration Needle EUS-25-0-N
EUDAMED
Class IIaActive
Endoscopic Ultrasound Aspiration Needle EUS-19-1-N
EUDAMEDFDA UDI
Class IIaActive

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