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Skynor Medical(Shanghai)Co.,Ltd

China·CN-MF-000028227

Last updated June 8, 2026

About

Skynor Medical was established in August 2014 at the Zhang Gang City International Medical Park, a high-technology enterprise dedicated to the development and manufacture of medical equipment for the central and outer vascular intervention of human beings, with a view to providing doctors and patients with high-quality holistic surgical solutions. Existing office, research and development and production sites of more than 3,000 m2 meet the requirements of the National Drug Control Authority and the ISO 13485 quality system。

Translated from the manufacturer's own website. Source

What Skynor Medical(Shanghai)Co.,Ltd makes

Skynor Medical manufactures a range of Hydrus devices, which appear to be designed for central and peripheral vascular interventions, as well as the SkyLoach product. These devices are likely intended for procedures involving blood vessels, including potential stenting or occlusion applications.

The company’s products are classified under EU medical device regulations as Class III and Class IIa, and they are registered in the EU’s eudamed database. Skynor Medical is based in Shanghai, China.

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 Skynor Medical(Shanghai)Co.,Ltd manufacture?

Skynor Medical(Shanghai)Co.,Ltd primarily manufactures a series of Hydrus devices, which are likely intended for central and peripheral vascular interventions. The company also produces the SkyLoach product. Based on the device names and classifications, these devices are designed for procedures involving blood vessels, such as stenting or occlusion treatments.

Where is Skynor Medical(Shanghai)Co.,Ltd based?

Skynor Medical(Shanghai)Co.,Ltd is headquartered in Shanghai, China. The company operates within a facility that includes office, research and development, and production spaces, ensuring compliance with relevant regulatory standards.

Which regulatory registries list Skynor Medical’s devices?

Skynor Medical’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track devices that have undergone conformity assessment procedures under EU regulations.

How are Skynor Medical’s devices classified under EU medical device regulations?

Skynor Medical’s devices are classified as Class III and Class IIa under EU medical device regulations. Class III devices are typically high-risk, such as those used in life-supporting or life-sustaining procedures, while Class IIa devices pose moderate risks. The classification determines the regulatory requirements for market authorization, such as clinical evaluations and conformity assessment procedures.

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

Information

Country
China
Address
908, Ziping Road,Pudong New area, Shanghai, China
LinkedIn
—
Facebook
—
Phone
+86 021 50670780
PRRC Contact
Haiping Li
EUDAMED SRN
CN-MF-000028227
FDA FEI Number
—
DUNS Number
—

Catalogue (267)

Page 1 of 6
DeviceModel / ReferenceRegistriesClassStatus
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
SkyLoach 07
EUDAMED
Class IIIActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
SkySurfer 04
EUDAMED
Class IIIActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
SkyLoach 07
EUDAMED
Class IIIActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
SkyLoach 07
EUDAMED
Class IIIActive
Microcatheter 05
EUDAMED
Class IIIActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
SkyLoach 07
EUDAMED
Class IIIActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
SkyFlow 03
EUDAMED
Class IIIActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive
Hydrus 02
EUDAMED
Class IIaActive

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