Data / Medical devices / China / Hicren (Zhejiang) Medtech Co., Ltd.
Hicren (Zhejiang) Medtech Co., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 1 510(k) clearance
Hicren (Zhejiang) Medtech Co., Ltd. is registered with the FDA (registration 3027518990) in Ningbo Zhejiang, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027518990
- Address
- Building 1& Ground Floor of Building 2, Block B, No.777, Binhai 4th Road, Hangzhou Bay New District, Ningbo Zhejiang, China, 315336
- Owner or operator
- Hicren (Zhejiang) Medtech Co., Ltd. (10088059)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- May 21, 2023
- Registered through
- 2026
- Brand names listed
- Balloon Inflation System, Bilateral PVP/PKP Set, Bone Biopsy Needle, Bone Cement Delivery Cannula, Bone Cement Mixing Set, Bone Drill, Dilator, Guidance System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Percutaneous, Biopsy | MJG | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | 1 | Exporter to the US, 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 29, 2024 | K232842 | Balloon Inflation System | NDN | Substantially Equivalent | Ningbo Hicren Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cement, Bone, Vertebroplasty
- All makers of Injector, Vertebroplasty (Does Not Contain Cement)
- All makers of Mixer, Cement, For Clinical Use
- All makers of Device, Percutaneous, Biopsy
- All makers of Spinal Channeling Instrument, Vertebroplasty
Updated February 29, 2024. 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.