Shenzhen Dazhou Medical Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 3 device types, 2 clearances.
Shenzhen Dazhou Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Drill, Dental, Intraoral, Orthopedic Manual Surgical Instrument and 1 other device type. Its earliest product listing with the FDA dates from 2024.
3device types registered with the FDA
2510(k) clearances
Registration
| Registered name | SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3031235905 |
| FEI number | 3031235905 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳大洲医学科技有限公司 |
|---|---|
| Unified social credit code | 91440300MA5FTJH08U |
| Source | NMPA UDI database |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Suite B605, Building No.1, YESUN INTELLIGENT COMMUNITY II, 1301-76 Guanguang Rd., Longhua District |
| Postal code | 518110 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | Fixture Mount/Transfer, Retaining Screw | 2026 | 70 |
| Drill, Dental, Intraoral | Class 1 | Step Drill | 2026 | 20 |
| Orthopedic Manual Surgical Instrument | Class 1 | Orthopedic manual surgical instrument | 2024 | 53 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241186 | 2025-02-21 | LYC | Traditional | This company |
| K241073 | 2024-12-06 | MAX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2019 |
|---|---|
| Main products | Hydrogel biomaterials, 3D-printed orthopedic implants, 3D-printed dental implants, Artificial bone materials, Bioprinting materials |
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.
The manufacturer named here can complete this record.