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Sign in to claim this brandSkynor 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
- Website
- www.skynormedical.com
- —
- —
- [email protected]
- Phone
- +86 021 50670780
- PRRC Contact
- Haiping Li
- EUDAMED SRN
- CN-MF-000028227
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (267)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| SkyLoach | 07 | EUDAMED | Class III | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| SkySurfer | 04 | EUDAMED | Class III | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| SkyLoach | 07 | EUDAMED | Class III | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| SkyLoach | 07 | EUDAMED | Class III | Active |
| Microcatheter | 05 | EUDAMED | Class III | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| SkyLoach | 07 | EUDAMED | Class III | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| SkyFlow | 03 | EUDAMED | Class III | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
| Hydrus | 02 | EUDAMED | Class IIa | Active |
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