FDA Registration Active 🇨🇳 China

C9-5ec

Reg #: 3005403518 · FEI: 3005403518 · Expires 2025
Products
3
Proprietary Names
37
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Philips Ultrasound (Shanghai) Co., Ltd
Registration Number
3005403518
FEI Number
3005403518
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Building 5, 3000 Longdong Boulevard, Suite 102, Suite 203, Suite 702
City
SHANGHAI
Country
CN

Regulatory Submissions

510(k) Number
K030455

Owner / Operator

Firm Name
Philips Medical Systems International BV
Operator Number
1217116
Address
Veenpluis 6
City
Best
State
NL-NOTA
Postal Code
5684PC
Country
NL

US Agent

Business Name
Bermudez
Contact Name
Ondrea Bermudez
Address
3721 Valley Centre Dr
City
San Diego
State
CA
ZIP
92130
Country
US
Phone
443 3200028

Products

Device Name Product Code
System, Imaging, Pulsed Doppler, Ultrasonic IYN
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Echo, Ultrasonic IYO

Proprietary Names

C9-5ec T6H X5-1 C10-3v X7-2t S8-3t L9-5 LAP C8-4v D2 TC L9-3 C5-2 S12-4 D2tcd L12-5 50mm S8-3 3D9-3v iU22 Diagnostic Ultrasound System C9-4 VL13-5 L11-3 iE33 Diagnostic Ultrasound System S7-3t D5cwc D2 CW D2cwc S3-1 L15-7io V6-2 X6-1 L8-4 L17-5 X7-2 S7-2omni T6207 C8-5 S4-1 L12-5 38mm

Establishment Types

Manufacture Medical Device