Shanghai Chenshi Medical Instruments Co., Ltd.
Registered establishment in Shanghai, China. 2 device types.
Shanghai Chenshi Medical Instruments Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Coil, Magnetic Resonance, Specialty, System, Nuclear Magnetic Resonance Imaging. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | SHANGHAI CHENSHI MEDICAL INSTRUMENTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012439308 |
| FEI number | 3012439308 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 上海辰时医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Room 206-207, Floor 2, Building 3, No. 8 of Area 3, No. 8228, Beiqing Road, Qingpu District |
| Postal code | 201700 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | Class 2 | Knee/Foot/Ankle Coil, multiple types, Pediatric Body-Cardiac Coil (4522-150-41131), Pediatric Head-Spine Coil (4522-133-18981), Pediatric Head-Spine Coil (Model: 5000012701), Pediatric Body-Cardiac Coil (Model: 5000012601), Pediatric Body-Cardiac Coil (4522-133-18721) and 1 more | 2018 | 9 |
| System, Nuclear Magnetic Resonance Imaging | Class 2 | Quad Head Coil T/R 3T, Shnc Driverbox 1.5T, Sense Flex S Coil 1.5T ODU, Sense Spine Coil 1.5T, Quad Head Coil 1.5T, Sense Flex S Coil 3T ODU and 11 more | 2018 | 12 |
Clearances
No clearance names Shanghai Chenshi Medical Instruments Co., Ltd. as applicant. 7 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K101949 | 2010-07-28 | MOS | Traditional | Shanghai Chenguang Medical Technologies Co., Ltd. |
| K101858 | 2010-07-14 | MOS | Traditional | Shanghai Chenguang Medical Technologies Co., Ltd. |
| K081340 | 2008-06-18 | MOS | Traditional | Shanghai Chenguang Medical Technologies Co., Ltd. |
| K081322 | 2008-06-18 | MOS | Traditional | Shanghai Chenguang Medical Technologies Co., Ltd. |
| K071847 | 2007-07-23 | MOS | Traditional | Shanghai Chenguang Medical Technologies Co., Ltd. |
| K052013 | 2005-08-02 | LNH | Traditional | Philips Medical Systems Nederland B.V. |
| K043147 | 2005-02-15 | LNH | Traditional | Philips Medical Systems North America, Inc. |
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.