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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 5 of 29

Device	Model / Reference	Registries	Class	Status
Reliant(TM) Multistage Dilatation Balloon Catheter	MBD-BS-BB-2	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	EBF33-11023230	FDA UDI	Class I	Active
Biliary Plastic Stent Set	BPDS-41993-1010/22	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	NBF63-11023230	FDA UDI	Class I	Active
Through the Scope Tracheal Stent System	NST12-334-16.050	FDA UDI	Class II	Active
eyeMAX(TM) Single-Use Biopsy Forceps	BF16002	FDA UDI	Class I	Active
Single-Use Biopsy Forceps	NBF13-01130230	FDA UDI	Class I	Active
Reliant(TM) Multistage Dilatation Balloon Catheter	MBD-DM-BB-2	FDA UDI	Class II	Active
Sphincterotome short-wire compatible	RDSP-0525-122	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-16/55-7/18-A	FDA UDI	Class II	Active
Retrieval Balloon short-wire compatible	RSRB-P-9/12/15-20	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-12/30-7/10-A	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	NBF03-11023180	FDA UDI	Class I	Active
Esophageal Stent System	NST01-222-18.150	FDA UDI	Class II	Active
Segmented Esophageal Stent System	NST61-224-20.100	FDA UDI	Class II	Active
Mt	MT-RGL-O-N	FDA UDI	Class II	Unknown
Single Use Multiclip Device	MC-3-26-195	FDA UDI	Class II	Active
Sterile Sphincterotome	DSP-30520-111121	FDA UDI	Class II	Active
SureClip	ROCC-D-26-270	FDA UDI	Class II	Unknown
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-41993-0705/17	FDA UDI	Class II	Active
Tracheal Stent system (OTW)	NST02-332-12.020	FDA UDI	Class II	Active
Sphincterotome short-wire compatible	RDSP-0530-131	FDA UDI	Class II	Active
Mt	IN12-255181802	FDA UDI	Class II	Unknown
Reliant(TM) Multistage Dilatation Balloon Catheter	MBD-DM-BA-2	FDA UDI	Class II	Active
Blue Beacon(TM) GI Marker	DYZ-08-10	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	EBF33-11023120	FDA UDI	Class I	Active
LesionHunter(TM) Rotatable Nitinol Cold Snare	CS2-22023231	FDA UDI	Class I	Active
Disposable Dilation Balloon	BDC-18/30-7/10-A	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-44114-1118/22	FDA UDI	Class II	Active
Biliary Plastic Stent	BPDS-44114-0812	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-44114-0705/17	FDA UDI	Class II	Active
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-41993-1010/22	FDA UDI	Class II	Active
Hemorrhoids Multiple Band Ligator Set	HMBLS-6F-NL	FDA UDI	Class II	Active
S.T.A.R(TM) Disposable Hemostatic Closure Clip Device	HCCD-0-165-M	FDA UDI	Class II	Active
Biliary Plastic Stent	BPDS-43114-0709	FDA UDI	Class II	Active
S.T.A.R(TM) Disposable Hemostatic Closure Clip Device	HCCD-0-165-L	FDA UDI	Class II	Active
SpiraTrax(TM) Sterile Hydro-Slide Guidewire	MTN-BM-89/26-A-W	FDA UDI	Class II	Active
Jumbo Single-Use Biopsy Forceps	JSNBF63-10033230	FDA UDI	Class I	Active
EdgeHog(TM) Polypectomy Snare	NRPFS03-01523230	FDA UDI	Class II	Active
Jumbo Single-Use Biopsy Forceps	JSNBF63-10128230	FDA UDI	Class I	Active
Mt	NBF02-11018120	FDA UDI	Class I	Unknown
Disposable Dilation Balloon	BDC-14/30-7/18-A	FDA UDI	Class II	Active
SureClip(®MINI) Repositionable Hemostasis Clip	ROCC-C-26-165-C-R	FDA UDI	Class II	Unknown
Single-Use Biopsy Forceps	SCNBF13-10122230	FDA UDI	Class I	Active
Through the Scope Tracheal Stent System	NST12-334-14.030	FDA UDI	Class II	Active
Tracheal Stent system (Y-shaped)	NST02-962-18.060-235	FDA UDI	Class II	Active
Ensure(TM) Single-Use Coagulation Forceps	CF165-C	FDA UDI	Class II	Active
SureClip(®) Repositionable Hemostasis Clip	ROCC-D-26-235-C-R	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-14/30-7/10-A	FDA UDI	Class II	Active
Sterile Biliary Stone Retrieval Balloon Catheter	SRB-T-18/21-20-G-B	FDA UDI	Class II	Active

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