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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 6 of 29

Device	Model / Reference	Registries	Class	Status
Biliary Plastic Stent	BPDS-41993-1003	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-15/80-7/10-A	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-44114-0818/22	FDA UDI	Class II	Active
Biliary Plastic Stent	BPDS-43114-1112	FDA UDI	Class II	Active
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-41993-0815/22	FDA UDI	Class II	Active
Single Use Multiclip Device	MC-3-30-165	FDA UDI	Class II	Active
Sterile Biliary Stone Retrieval Balloon Catheter	SRB-T-9/12-20-B	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-44114-0815/22	FDA UDI	Class II	Active
S.T.A.R(TM) Disposable Hemostatic Closure Clip Device	HCCD-1-235-L-C	FDA UDI	Class II	Active
SureTrac(TM) Elastic Traction System	ETS10007	FDA UDI	Class II	Active
Sterile Biliary Stone Retrieval Balloon Catheter	SRB-T-15/18/21-20	FDA UDI	Class II	Active
ABC Dilatation Balloon Catheter	FWB-12/55-6/23-S	FDA UDI	Class II	Active
Single Use Electrosurgical Knife	MK-T-4-235	FDA UDI	Class II	Active
Tracheal Stent system (OTW)	NST02-332-20.060	FDA UDI	Class II	Active
Esophageal Stent System	NST01-222-22.080	FDA UDI	Class II	Active
eyeMAX(TM) Single-use Video Pancreaticobiliary Scope	CDS22002	FDA UDI	Class I	Active
Tracheal Stent system (OTW)	NST02-334-18.070	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-43114-1115/22	FDA UDI	Class II	Active
Mt	100572	FDA UDI	Class I	Unknown
SureClip	ROCC-D-26-235-C	FDA UDI	Class II	Unknown
Single-Use Biopsy Forceps	EBF43-11023230	FDA UDI	Class I	Active
Disposable Dual Action Tissue Closure Device	STA00002	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-43114-1018/22	FDA UDI	Class II	Active
Biliary Plastic Stent	BPDS-43114-0712	FDA UDI	Class II	Active
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-41993-0805/22	FDA UDI	Class II	Active
Cytology Brush	CYB-50S-12C	FDA UDI	Class II	Active
Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)	EUS-22-0-CS1	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	NBF13-11123180	FDA UDI	Class I	Active
Esophageal Stent System	NST01-222-18.120	FDA UDI	Class II	Active
Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)	EUS-25-0-CS1	FDA UDI	Class II	Active
Polypectomy Snare	NPFS02-02023230	FDA UDI	Class II	Active
Lockado(TM) Repositionable Hemostasis Clip	LOCK-F-26-270-C-N	FDA UDI	Class II	Active
Sphincterotome short-wire compatible	RDSP-0530-121	FDA UDI	Class II	Active
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)	EUS-19-0-FS2	FDA UDI	Class II	Active
Spray Catheter	WP-23/2200	FDA UDI	Class I	Active
eyeMAX(TM) Extraction Basket	CEB00003	FDA UDI	Class II	Active
Extraction Basket	RSEB-S8-20	FDA UDI	Class II	Active
SureClip	ROCC-D-26-165-C	FDA UDI	Class II	Unknown
SureClip	ROCC-C-26-235-C	FDA UDI	Class II	Unknown
Sterile Biliary Stone Retrieval Balloon Catheter	SRB-T-15/18-20-G	FDA UDI	Class II	Active
Mt	NBF02-11023230-A	FDA UDI	Class I	Unknown
Disposable Dilation Balloon	BDC-16/30-7/24-A	FDA UDI	Class II	Active
Retrieval Balloon short-wire compatible	RSRB-T-9/12/15-20	FDA UDI	Class II	Active
Esophageal Stent System	NST01-224-18.060	FDA UDI	Class II	Active
EnTrap(TM) Polyp Retrieval Snare Net	NT-E-30/16-P	FDA UDI	Class I	Active
Ensure(TM) Single-Use Coagulation Forceps	CF230-A	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-41993-1005/22	FDA UDI	Class II	Active
Mt	NMI-05	FDA UDI	Class II	Unknown
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-44114-0712/17	FDA UDI	Class II	Active
Sphincterotome short-wire compatible	RDSP-0520-211	FDA UDI	Class II	Active

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