Aike (Shanghai) Medical Instrument Co., Ltd.
Registered establishment in Shanghai, China. 4 device types, 1 clearance.
Aike (Shanghai) Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Pin, Fixation, Threaded, Tourniquet, Nonpneumatic and 2 other device types. Its earliest product listing with the FDA dates from 2021.
4device types registered with the FDA
1510(k) clearance
Registration
| Registered name | AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018269629 |
| FEI number | 3018269629 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 埃客（上海）医用设备有限公司 |
|---|---|
| Unified social credit code | 91310114687381611D |
| Source | NMPA UDI database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Room F201, Floor2, Building 6, No.125, LongPan Road, Malu Town, Jiading District, 201801, Shanghai, China |
| Postal code | 201801 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | ZS6, Bfix® Orthopedic External Fixator Systems, ZS7 | 2021 | 17 |
| Orthopedic Manual Surgical Instrument | Class 1 | Bfix Instruments | 2023 | 53 |
| Pin, Fixation, Threaded | Class 2 | ZS6, Bfix® Orthopedic External Fixator Systems, ZS7 | 2021 | 9 |
| Tourniquet, Nonpneumatic | Class 1 | AK-SET008, AK-SET005, AK-SET003, AK-SET009, AK-SET007, AK-SET006 and 3 more | 2026 | 124 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200491 | 2021-01-05 | KTT | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Orthopedic implants, Medical instruments, Surgical power tools |
|---|
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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