MediConcepts Technology (Shenzhen) Company Limited
Registered establishment in Shenzhen, Guangdong, China. 5 device types, 1 clearance.
MediConcepts Technology (Shenzhen) Company Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Laryngoscope, Rigid, Accessory, Surgical Apparel and 3 other device types. Its earliest product listing with the FDA dates from 2014.
5device types registered with the FDA
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3010806653 |
| FEI number | 3010806653 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 医创建科技（深圳）有限公司 |
|---|---|
| Unified social credit code | 914403000733893282 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Building 37 Tong Fu Industrial Estate, |
| Postal code | 518120 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face ShieldOR | 2020 | 439 |
| Bedding, Disposable, Medical | Class 1 | Body BagOR | 2020 | 308 |
| Laparoscope, General & Plastic Surgery | Class 2 | Reveel, Standard Trocar | 2021 | 46 |
| Laryngoscope, Rigid | Class 1 | X Blade | 2014 | 44 |
| System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | Class 3 | Prolieve Thermodilatation System | 2025 | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232042 | 2023-10-20 | GCJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | Medical device design, Medical device manufacturing, Contract design and manufacturing |
| Certifications | ISO13485, cGMP |
| Export markets | International |
| OEM and ODM | Offered |
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.