GE Healthcare (China) Co., Ltd. – Tianjin
Registered establishment in Tianjin, China. 3 device types.
GE Healthcare (China) Co., Ltd. – Tianjin is a specification developer holding a current FDA establishment registration. The registration covers Coil, Magnetic Resonance, Specialty, System, Nuclear Magnetic Resonance Imaging and 1 other device type. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | GE HEALTHCARE (CHINA) CO., LTD. – Tianjin |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013343065 |
| FEI number | 3013343065 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | No. 1, inside No. 266 Jing San Road |
| Postal code | 300308 |
| Country | China |
Group
GE Healthcare (China) Co., Ltd. – Tianjin is one of 5 plants registered under GE HealthCare Technologies Inc..
| Plant | City | Device types |
|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | 22 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | 57 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | 5 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | Class 2 | SIGNA Sprint Select, SIGNA Artist Evo, 1.5T TDI Head Neck Array, SIGNA Voyager Quantum, 1.5T TDI Posterior Array, Signa Voyager Premier Edition and 9 more | 2017 | 9 |
| System, Nuclear Magnetic Resonance Imaging | Class 2 | SIGNA Prime Elite, SIGNA Sprint Select, SIGNA Hero, SIGNA Artist Evo, 1.5T TDI Head Neck Array, SIGNA Voyager Quantum and 19 more | 2015 | 12 |
| System, Nuclear Magnetic Resonance Spectroscopic | Class 2 | SIGNA Prime Elite, SIGNA Sprint Select, SIGNA Hero, SIGNA Artist Evo, SIGNA Artist, SIGNA Champion and 2 more | 2020 | 4 |
Clearances
No clearance names GE Healthcare (China) Co., Ltd. – Tianjin as applicant. 12 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 |
|---|---|---|---|---|
| K253779 | 2026-02-05 | LNH | Traditional | GE Medical Systems, LLC |
| K251399 | 2025-09-11 | LNH | Traditional | GE Medical Systems, LLC |
| K250379 | 2025-03-17 | LNH | Traditional | GE Medical Systems, LLC |
| K233728 | 2024-01-19 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K223439 | 2023-02-13 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K213603 | 2022-02-11 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K213668 | 2022-01-20 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
| K211980 | 2022-01-16 | LNH | Traditional | GE Healthcare (Tianjin) Company Limited |
| K202238 | 2020-09-04 | LNH | Special | GE Healthcare (Tianjin) Company Limited |
| K192426 | 2019-10-01 | LNH | Special | GE Healthcare (Tianjin) Company Limited |
| K160621 | 2016-03-29 | LNH | Special | GE Healthcare GmbH |
| K143251 | 2015-02-04 | LNH | Traditional | Ge Healthcare (Ge Medical Systems, LLC) |
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.