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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 4 of 29

Device	Model / Reference	Registries	Class	Status
Single-Use Biopsy Forceps	LCNBF13-10124180	FDA UDI	Class I	Active
eyeMAX(TM) Extraction Basket	CEB02021	FDA UDI	Class II	Active
Tracheal Stent system (OTW)	NST02-334-10.030	FDA UDI	Class II	Active
Single Use Electrosurgical Knife	MK-I-2-195	FDA UDI	Class II	Active
Mt	IN12-256182302	FDA UDI	Class II	Unknown
Disposable Dilation Balloon	BDC-30/80-7/24-A	FDA UDI	Class II	Active
Luminscan(TM) Disposable Imaging Kit	BOP-20-80-25-7	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-12/80-7/10-A	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-41993-0712/17	FDA UDI	Class II	Active
Retrieval Balloon short-wire compatible	RSRB-P-12/15/18-20-G	FDA UDI	Class II	Active
Reliant(TM) Multistage Dilatation Balloon Catheter	MBD-DL-BA-2	FDA UDI	Class II	Active
Disposable Dual Action Tissue Closure Device	STA00004	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-10/30-7/10-A	FDA UDI	Class II	Active
Tracheal Stent system (OTW)	NST02-334-12.080	FDA UDI	Class II	Active
Mt	NBF03-11023230-A	FDA UDI	Class I	Unknown
SureClip	ROCC-F-26-235-C	FDA UDI	Class II	Unknown
eyeMAX(TM) Single-Use Biopsy Forceps	BF16001	FDA UDI	Class I	Active
Retrieval Balloon short-wire compatible	RSRB-P-15/18-20-G-B	FDA UDI	Class II	Active
Tracheal Stent system (Y-shaped)	NST02-962-20.050-110	FDA UDI	Class II	Active
Tracheal Stent system (Y-shaped)	NST02-962-20.060-111	FDA UDI	Class II	Active
Single-Use Video Bronchoscope	SVB22001	FDA UDI	Class II	Active
RiteClip(TM) Repositionable Hemostasis Clip	ROCC-D-26-195-C	FDA UDI	Class II	Active
Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)	EUS-19-0-CS1	FDA UDI	Class II	Active
Luminscan(TM) Disposable Imaging Kit	BOP-18-30-25-7	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	SCNBF13-10022230	FDA UDI	Class I	Active
Single-Use Biopsy Forceps	NBF03-01130230	FDA UDI	Class I	Active
S.T.A.R(TM) Disposable Hemostatic Closure Clip Device	HCCD-0-235-M	FDA UDI	Class II	Active
Multiple Band Ligator Set	MBLS-7F	FDA UDI	Class II	Active
Biliary Plastic Stent	BPDS-41993-1015	FDA UDI	Class II	Active
Reliant(TM) Multistage Dilatation Balloon Catheter	MBD-BS-BB-2	FDA UDI	Class II	Active
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-43114-0805/22	FDA UDI	Class II	Active
SureClip(®) Repositionable Hemostasis Clip	ROCC-D-26-235-C-N	FDA UDI	Class II	Active
Biliary Plastic Stent Set	BPDS-44114-1109/22	FDA UDI	Class II	Active
eyeMAX(TM) Extraction Basket	CEB01013	FDA UDI	Class II	Active
Tracheal Stent system (Y-shaped)	NST02-962-18.060-239	FDA UDI	Class II	Active
Tracheal Stent system (OTW)	NST02-332-14.060	FDA UDI	Class II	Active
Biliary Plastic Stent Set/ short-wire compatible	RBPDS-43114-0705/17	FDA UDI	Class II	Active
Biliary Plastic Stent	BPDS-41993-1005	FDA UDI	Class II	Active
ABC Dilatation Balloon Catheter	FWB-18/55-6/23-S	FDA UDI	Class II	Active
Mt	MBLS-XS-6F-NL	FDA UDI	Class II	Unknown
Esophageal Stent System	NST01-222-20.150	FDA UDI	Class II	Active
Injection Needle	IN12-254232002	FDA UDI	Class II	Active
SureClip	ROCC-F-26-270-C	FDA UDI	Class II	Unknown
Sterile Biliary Stone Retrieval Balloon Catheter	SRB-T-9/12/15-20-G-B	FDA UDI	Class II	Active
Sterile Sphincterotome	DSP-30520-111221	FDA UDI	Class II	Active
Single Use Electrosurgical Knife	MK-IT-4-195-N	FDA UDI	Class II	Active
BlueBoost(TM) Submucosal Injectable Solution	SML10	FDA UDI	Class II	Active
Mt	MBLS-XS-4F	FDA UDI	Class II	Unknown
Disposable Bite Block	AC01-103.A	FDA UDI	Class I	Active
Polypectomy Snare	NPFS02-02423230	FDA UDI	Class II	Active

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