Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016609702

FEI Number

3016609702

Entity Name

MICROPORT NEUROTECH (SHANGHAI) CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Building #16, 222 Guangdan Road, Pudong New District, Shanghai 201318, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MicroPort NeuroTech (Shanghai) Co., Ltd. (Owner Number: 10082955)

Owner / Operator Contact Address

Building #16, 222 Guangdan Road, Pudong New District, Shanghai, CN-SH 201318, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203625

PMA Number

N/A

All Registered Proprietary Names

Numen Coil Embolization System; NumenFR Detachment System Numen Helia Coil Embolization System; NumenFR Detachment System Numen Coil Embolization System; NumenFR Detachment System Numen Coil Embolization System; NumenFR Detachment System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-04-10
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-04-10
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2026-06-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2026-06-04
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-10-31
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-10-31
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2022-02-09
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-02-09

Official Correspondent

Zou Qiuhua

US Agent Details

Yiqun Bruce Wang Email: Bruce.Wang@microport.com Phone: (510) 7895920

Related Public Records

Same Entity

MicroPort NeuroTech (Shanghai) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08

Similar Registrations

Registration Number	Establishment Name	Location
9615728	BIOSPHERE MEDICAL, S.A.	Roissy Val-d'Oise, FR
2029275	Sterigenics U.S., LLC	Corona, CA, US
3008853977	Stryker Neurovascular	Fremont, CA, US
2022435	Sterigenics U.S., LLC	Tustin, CA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016609702. Last updated year: 2026. Please use registration number 3016609702 when referencing this establishment in official correspondence.