Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010047475

FEI Number

3010047475

Entity Name

PT PHILIPS INDUSTRIES BATAM

City/State/Country

Muka Kuning, Batam Riau, ID

Establishment Address

Jalan Ahmad Yani - Panbil Industrial Estate, B1 Lot 1-6, B2A Lot 12-17, Muka Kuning, Batam Riau 29433, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 9005541)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PHILIPS AVENT NIPPLE SHIELD AirFloss Fill and Charge Station AirFloss Ultra Power Flosser & Toothbrush System AirFloss Pro Philips Power Flosser 7000 Power Flosser Nozzle pack( F1,F2,F3) AirFloss Philips Power Flosser 3000 Philips Sonicare Cordless Power Flosser 3000 Philips Sonicare Cordless Power Flosser 2000 Philips Sonicare Compact Flosser 1000 Philips Sonicare Compact Flosser replacement nozzles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2024-04-17
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2011-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

Shaylee Masilunas Business: Philips Email: shaylee.masilunas@philips.com Phone: (724) 8162019

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

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3009124884	Essentia Industries Ltd.	Dong Guan Guangdong, CN
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3036893546	JIANGSU SENWO MEDICAL TECHNOLOGY CO., LTD.	Nantong Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010047475. Last updated year: 2026. Please use registration number 3010047475 when referencing this establishment in official correspondence.