Suzhou Zenith Vascular SciTech Limited
Active in EUDAMEDChinafrom EUDAMED address EUDAMED FDA SRN CN-MF-000050362 FEI 3039020025
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
Catalogue
Zenith Distal Access Long Sheath Ref K253359
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Micro Catheter Ref K243534
Regimes: 510(k) Registry: 510(k)Zenith Micro Guidewire Ref K252317
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000050362
- FDA FEI number
- 3039020025
- EU VAT number
- 91320594MA1WKN341T
- EUDAMED status
- Active
- EUDAMED registered name
- Suzhou Zenith Vascular SciTech Limited
- EUDAMED abbreviated name
- Zenith Vascular
- Address
- Ground Floor to 5th Floor, Underground Unit B102, Building 6, Block B, Phase 5, Biobay, Suzhou Jiangsu
- Website
- www.zenithmedtech.com
- [email protected]
- Phone
- +86-0512-66174311
- PRRC contact
- Chao Zhang
From the company website
Suzhou Zenith Vascular Co., Ltd. is a pioneering enterprise established in 2018, dedicated to providing innovative solutions for vascular diseases. Our mission is to become the leading provider of vascular solutions through innovation that creates easier and more effective endovascular treatments. With a strong foundation in independent R&D, we partner with top clinical experts worldwide to develop high-quality vascular interventional products that meet diverse clinical needs. Our mature technology platforms and in-house manufacturing system ensure consistent quality and efficiency from concept to clinical use. By focusing on innovation, quality, and continuous improvement, Zenith has become a trusted provider of cutting-edge solutions—empowering physicians and improving patient outcomes globally.
Frequently asked questions
How many devices does Suzhou Zenith Vascular SciTech Limited have in the registry?
The registry currently lists 4 devices for Suzhou Zenith Vascular SciTech Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Zenith Vascular SciTech Limited's devices?
Among its 4 most recently registered devices, Suzhou Zenith Vascular SciTech Limited has devices listed in FDA 510(k) (4 devices).
What risk classes do Suzhou Zenith Vascular SciTech Limited's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Suzhou Zenith Vascular SciTech Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suzhou Zenith Vascular SciTech Limited in the registry?
The most recently registered devices listed for Suzhou Zenith Vascular SciTech Limited include Zenith Distal Access Long Sheath, Zenith Aspiration Catheter; Disposable Aspiration Tubing Set, Micro Catheter and Zenith Micro Guidewire.