Ningbo Hicren Biotechnology Co., Ltd.
Registered establishment in Ningbo, Zhejiang, China. 5 device types, 1 clearance.
Ningbo Hicren Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cement, Bone, Vertebroplasty, Device, Percutaneous, Biopsy and 3 other device types. Its earliest product listing with the FDA dates from 2023.
5device types registered with the FDA
1510(k) clearance
Registration
| Registered name | NINGBO HICREN BIOTECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027518990 |
| FEI number | 3027518990 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 宁波华科润生物科技有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Ningbo |
|---|---|
| Province | Zhejiang |
| Address | Building 1& Ground Floor of Building 2, Block B, No.777, Binhai 4th Road, Hangzhou Bay New District |
| Postal code | 315336 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | Class 2 | Balloon Inflation System | 2024 | 5 |
| Device, Percutaneous, Biopsy | Class 1 | Bone Biopsy Needle | 2023 | 5 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Class 1 | PCVP Set, Bone Cement Delivery Cannula | 2023 | 5 |
| Mixer, Cement, For Clinical Use | Class 1 | Bone Cement Mixing Set | 2023 | 14 |
| Spinal Channeling Instrument, Vertebroplasty | Class 1 | Dilator, Percutaneous Access Needle, Location Plate, Guidance System, Bilateral PVP/PKP Set, Bone Drill and 1 more | 2023 | 5 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232842 | 2024-02-29 | NDN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | spinal implants, orthopedic devices, medical robots |
| Certifications | CFDA, CE |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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