Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC
Registered establishment in Shanghai, China. 6 device types.
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC is a specification developer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrocardiograph and 4 other device types. Its earliest product listing with the FDA dates from 2003.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3012027770 |
| FEI number | 3012027770 |
| Establishment type | Specification developer, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | Building A1, #718 Lingshi Road |
| Postal code | 200072 |
| Country | China |
Group
Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC is one of 5 plants registered under Philips Medical Systems International BV.
| Plant | City | Device types |
|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | 5 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | 5 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | 1 |
| Philips Goldway (Shenzhen) Industrial Inc. | Shenzhen | 7 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Omni-Trak 3000 Series, M1626A ECG Cable, CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd – 989803176161, M1681A ECG Cable, M1673A ECG Cable, M1934A EEG Leadset and 39 more | 2003 | 47 |
| Computer, Diagnostic, Programmable | Class 2 | IntelliSpace ECG SW, IntelliSpace ECG, ST80i Stress Test System w/ Printer, Lead Sets, Electrodes, 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps, 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber, 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps and 2 more | 2012 | 10 |
| Electrocardiograph | Class 2 | PageWriter TC35 Cardiograph, TC35 (860437), 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951, PageWriter TC20, TC30, TC50, TC70 w/PIM, Lead Sets, Adapters, Electrodes, PageWriter TC20, 989803175921, 12-Lead Patient Cable (AAMI), Long, 989803175891, 12-Lead Patient Cable (IEC), Standard Length and 23 more | 2009 | 18 |
| Electrocardiograph, Ambulatory (Without Analysis) | Class 2 | DigiTrak XT Holter Recorder w/Leadwires, 989803157491, DigiTrak XT Patient Cable, Medium, 989803157501, DigiTrak XT Patient Cable, Long, 989803157481, DigiTrak XT Patient Cable, Short, DL950 Holter System | 2009 | 4 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | Class 2 | Holter 1810/ 2010 SW | 2016 | 2 |
| Electrode, Electrocardiograph | Class 2 | Quadtrode CV MRI ECG Electrode Pad – 989803179041, Quadtrode MRI ECG PAD,25/BOX – 989803179031, 40494E, Limb Clamp Electrode, Neonatal Quadtrode MRI ECG Electrode Pad – 989803179051, MCOT Patch, Patch and 12 more | 2022 | 33 |
Clearances
No clearance names Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC as applicant. 8 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 |
|---|---|---|---|---|
| K241556 | 2024-12-17 | DPS | Traditional | Philips Medizin Systeme Böblingen GmbH |
| K221141 | 2022-12-02 | DPS | Traditional | Medizin Systeme Boblingen GmbH |
| K121638 | 2012-07-18 | DQK | Traditional | Philips Health Care |
| K120855 | 2012-06-29 | DQK | Traditional | Philips Health Care |
| K113144 | 2012-04-03 | DPS | Traditional | Philips Medical Systems Technologies Ltd |
| K080999 | 2008-05-09 | DPS | Special | Philips Medical Systems Technologies Ltd |
| K071733 | 2007-07-24 | MWJ | Special | Braemar, Inc. |
| K010949 | 2001-09-28 | MLO | Traditional | Agilent Technologies, Inc |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | MRI systems, CT scanners, Ultrasound equipment, Patient monitoring |
|---|---|
| Export markets | Global |
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.