Philips Goldway (Shenzhen) Industrial Inc.
Registered establishment in Shenzhen, Guangdong, China. 7 device types.
Philips Goldway (Shenzhen) Industrial Inc. is a specification developer holding a current FDA establishment registration. The registration covers Oximeter, Alarm, Blood-Pressure and 5 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3003687189 |
| FEI number | 3003687189 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | No.2 Keji North 3rd Road |
| Postal code | 518057 |
| Country | China |
Group
Philips Goldway (Shenzhen) Industrial Inc. is one of 5 plants registered under Philips Medical Systems International BV.
| Plant | City | Device types |
|---|---|---|
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | 6 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | 5 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | 5 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Alarm, Blood-Pressure | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 7 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 29 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 22 |
| Computer, Blood-Pressure | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 12 |
| Continuous Measurement Thermometer | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 115 |
| Oximeter | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 70 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | EarlyVue VS30 Vital Signs Monitor, EarlyVue VS30 (863380) | 2019 | 98 |
Clearances
No clearance names Philips Goldway (Shenzhen) Industrial Inc. as applicant. One is held by another company 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 |
|---|---|---|---|---|
| K190624 | 2019-10-27 | DSJ | Traditional | Philips Medizin Systeme Boeblingen GmbH |
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.