Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023222182

FEI Number

3023222182

Entity Name

MAPAEX HEALTH AND PERSONALCARE IRELAND PRIVATE LIMITED

City/State/Country

Newbridge Kildare, IE

Establishment Address

Green Road, Newbridge Kildare W12X905, IE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mapaex Health And Personalcare Ireland Private Limited (Owner Number: 10085384)

Owner / Operator Contact Address

Green Road, Newbridge, IE-KE W12X905, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oral B Pro Health Clinical Pro Flex. OM066 OB PULS DPCL 35M 1CT MEA FPC OK003 OBKIDS CRSFRZ 3+Y S 1CT MEA FPC OB ADV 3DW FRESH 35S 1CT MEA FPC OM132 OB CLS3Eff 40M 3ct MEA FPC OK001 OB BABWIN 0-2YR XS 1CT MEA FPC OK011 OBKIDS STRWRS 6+Y S 1CT MEA FPC OM066 OB PULS 3DW WTNG 35S 1CT MEA FPC OM009 OB Pro Exp AIO Med 40 MEA FPC Oral-B Charcoal Electric Toothbrush Replacement Brush Heads Refill. Glide Multiprotection Ariel II-Floss

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2022-06-10
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2022-06-10
JES	Floss, Dental	Dental	Class 1	872.6390	2022-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Mapaex Health And Personalcare Ireland Private Limited

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

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3015913483	GRAND S KOREA CO., LTD.	Goyang-si Gyeonggi, KR
3043840120	CURIDENT, LLC	Boca Raton, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023222182. Last updated year: 2026. Please use registration number 3023222182 when referencing this establishment in official correspondence.