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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 2 of 29

Device	Model / Reference	Registries	Class	Status
Sterile Hot Snare	PFS02-02423180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-51023230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-03023160	EUDAMED	Class IIb	Active
Single Use Hybrid Snare	CH01-52023230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-01023180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-01523160	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-02423180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-02023250	EUDAMED	Class IIb	Active
Specimen Pad	BBD-03	EUDAMED	Class I	Active
Sterile Hot Snare	PFS01-51023180	EUDAMED	Class IIb	Active
Single Use Hybrid Snare	CH01-51523230	EUDAMED	Class IIb	Active
Single Use Hybrid Snare	CH01-01523180	EUDAMED	Class IIb	Active
Nitinol Spiral Extraction Basket	SEB131/2070200-P	EUDAMED	Class IIa	Active
Single Use Hybrid Snare	CH01-51023180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-02023250	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-52023180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-02023230	EUDAMED	Class IIb	Active
Single Use Hybrid Snare	CH01-51023230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-03623180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-03023250	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-01023160	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-12023230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS04-02023180	EUDAMED	Class IIb	Active
Nitinol Spiral Extraction Basket	SEB121/1570200-P	EUDAMED	Class IIa	Active
Sterile Hot Snare	PFS01-12423230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-02423230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-03623230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-11523230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-12023180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-02023180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-51523230	EUDAMED	Class IIb	Active
Visualized Access and Delivery Catheter Slim	CDS55001	EUDAMED	Class IIa	Active
Single Use Hybrid Snare	CH01-01023180	EUDAMED	Class IIb	Active
Nitinol Spiral Extraction Basket	RSEB-S8-20	EUDAMED	Class IIa	Active
Nitinol Spiral Extraction Basket	SEB131/2570200-P	EUDAMED	Class IIa	Active
Sterile Hot Snare	PFS02-51523180	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-01023230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS02-03023230	EUDAMED	Class IIb	Active
Sterile Hot Snare	PFS01-52523180	EUDAMED	Class IIb	Active
Visualized Access and Delivery Catheter Slim	CDS44013	EUDAMED	Class IIa	Active
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)	EUS-22-0-FS1	FDA UDI	Class II	Active
Through the Scope Tracheal Stent System	NST12-334-10.040	FDA UDI	Class II	Active
Tracheal Stent system (OTW)	NST02-334-14.030	FDA UDI	Class II	Active
Esophageal Stent System	NST01-224-22.100	FDA UDI	Class II	Active
Retrieval Balloon short-wire compatible	RSRB-T-15/18/21-20-B	FDA UDI	Class II	Active
Disposable Dilation Balloon	BDC-25/80-7/24-A	FDA UDI	Class II	Active
Extraction Basket	RSEB-S4-20	FDA UDI	Class II	Active
Injection Needle	IN12-253232302	FDA UDI	Class II	Active
Esophageal Stent System	NST01-222-20.100	FDA UDI	Class II	Active
Single-Use Biopsy Forceps	EBF43-11023120	FDA UDI	Class I	Active

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Shanghai International Holding Corp. GmbH(Europe) DE

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