FDA Registration Active 🇧🇷 Brazil

B800-500 BiliCal; 50 Pack

Reg #: 3014541700 · FEI: 3014541700 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Philips Medical Systems Ltda
Registration Number
3014541700
FEI Number
3014541700
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Avenida Otto Selgado, 250
City
Varginha Minas Gerais
Country
BR

Regulatory Submissions

510(k) Number
K010052

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
PHILIPS
Contact Name
Deborah Currlin
Address
222 Jacobs Street
City
Cambridge
State
MA
ZIP
02140
Country
US
Phone
858 9452753

Products

Device Name Product Code
Bilirubin (Total And Unbound) In The Neonate Test System MQM

Proprietary Names

B800-500 BiliCal; 50 Pack 1037632 Bilichek (Advanced)

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility