Data / Medical devices / China / Viant Medical SUZHOU EPZ Co., Ltd
Viant Medical SUZHOU EPZ Co., Ltd: FDA-registered device maker in Jiangsu Province, China, 1 510(k) clearance
Viant Medical SUZHOU EPZ Co., Ltd is registered with the FDA (registration 3006194679) in Jiangsu Province, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2011. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006194679
- Address
- 288 Shengpu Road, Suzhou Industrial Park, Suzhou, Jiangsu Province, China, 215021
- Owner or operator
- Viant Medical, LLC (9043339)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- November 13, 2013
- Registered through
- 2027
- Brand names listed
- Archimedes Pro Disposable Tubing Set, Archimedes Pro Plus Disposable Tubing Set, Archimedes Standard Disposable Tubing Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion, Insulin | LZG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Peritoneal, Automatic Delivery | FKX | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2011 | K103825 | V-GO INSULIN DELIVERY SYSTEM | LZG | Substantially Equivalent | Valeritas, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Infusion, Insulin
- All makers of Set, Administration, Intravascular
- All makers of System, Peritoneal, Automatic Delivery
Updated February 23, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.