Data / Medical devices / China / Novo Nordisk (China) Pharmaceuticals, Co. Ltd.
Novo Nordisk (China) Pharmaceuticals, Co. Ltd.: FDA-registered device maker in Tianjin, China, 1 510(k) clearance
Novo Nordisk (China) Pharmaceuticals, Co. Ltd. is registered with the FDA (registration 3005186124) in Tianjin, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 17, 2018. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005186124
- Address
- 99 Nanhai Road TEDA, Tianjin, China, 300457
- Owner or operator
- NOVO NORDISK INC. (9027307)
- Roles
- Manufacturer
- First device listed
- January 22, 2019
- Registered through
- 2026
- Brand names listed
- NovoPen Echo
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Syringe, Piston | FMF | 2 | 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 |
|---|---|---|---|---|---|---|
| December 17, 2018 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | Substantially Equivalent | Novo Nordisk, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 17, 2018. 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.