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Shanghai Microport Ep Medtech Co., Ltd.

Last updated May 30, 2026

Part of Shanghai Microport Ep Medtech Co., Ltd.

What Shanghai Microport Ep Medtech Co., Ltd. makes

The company manufactures single-use cardiac mapping catheters with fixed curve designs for diagnostic procedures, as well as percutaneous transseptal access sets for guiding interventions across the atrial septum. These devices are intended for use in electrophysiological studies and structural heart interventions.

The portfolio consists of Class II devices listed in the FDA’s Unique Device Identification (UDI) system. The manufacturer operates from 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 Shanghai Microport Ep Medtech Co., Ltd. manufacture?

Shanghai Microport Ep Medtech Co., Ltd. specializes in single-use cardiac devices. Their portfolio includes cardiac mapping catheters with fixed curve designs, primarily for diagnostic electrophysiological studies, and percutaneous transseptal access sets used to guide interventions across the atrial septum. These devices are tailored for procedures like structural heart interventions.

Where is Shanghai Microport Ep Medtech Co., Ltd. based?

The company operates from the United States, though its manufacturing may occur in China (Shanghai). The U.S. presence is relevant for regulatory engagement, particularly with the FDA’s UDI system, where their devices are listed.

Are Shanghai Microport Ep Medtech Co., Ltd.’s devices listed in any regulatory registries?

Yes, the company’s devices are included in the FDA’s Unique Device Identification (UDI) system. This registry tracks Class II medical devices authorized for commercial distribution in the U.S., ensuring traceability and compliance with regulatory requirements.

How are Shanghai Microport Ep Medtech Co., Ltd.’s devices classified under U.S. regulations?

All of the company’s listed devices fall under Class II classification in the U.S. This classification applies to devices that pose moderate risk and require special controls (e.g., performance standards or post-market surveillance) to ensure safety and effectiveness without requiring pre-market approval.

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

Information

Country: US
Address: —
Website: —
LinkedIn: —
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 542965535

Catalogue (109)

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Device	Model / Reference	Registries	Class	Status
EasyFinder Fixed Curve Diagnostic Catheter	EPD6DD252	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6FD005	FDA UDI	Class II	Active
PathBuilder Transseptal Needle	C.6H.M98	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL3638	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6AD010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSR28185	FDA UDI	Class II	Active
PathBuilder Steerable Introducer	C.GK.X71	FDA UDI	Class II	Active
PathBuilder Transseptal Needle	C.6H.S56	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6FB010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL2638	FDA UDI	Class II	Active
PathBuilder Steerable Introducer	C.GK.M61	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD5JG010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL48185	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6CG010	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6FD252	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6AB010	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6FD010	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6PE282	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6AD010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSR2818	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6PC282	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL0818	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6PC282	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6PE282	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6AD005	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6DD005	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6AB010	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6DD010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL48185	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD5PE282	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6DB005	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6FB005	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL4818	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6FB005	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6AB010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSR46385	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSR4638	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL18185	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6DB005	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6FD005	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSR4818	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD5CG010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL46385	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL0638	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6AB005	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic Catheter	EPD6CG010	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSL4638	FDA UDI	Class II	Active
PathBuilder Transseptal Guiding Introducer	TSR0818	FDA UDI	Class II	Active
PathBuilder Transseptal Needle	C.6H.M71	FDA UDI	Class II	Active
EasyFinder Fixed Curve Diagnostic catheter	EPD6AD252	FDA UDI	Class II	Active

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