Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008478778

FEI Number

3008478778

Entity Name

MAM Hungária Kft.

City/State/Country

Vaskeresztes, HU

Establishment Address

Fö ut 132, Vaskeresztes 9795, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAM Baby AG (Owner Number: 9054867)

Owner / Operator Contact Address

Sihleggstrasse 15, Wollerau, CH-SZ 8832, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bite & Relax Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) MAM Nipple shield size 1 and 2 MAM Manual Breast Pump Training Brush First Brush Baby's Brush with Safety Shield Preemie 1 MAM Comfort size 1 Preemie 2 MAM Perfect Pacifier MAM Comfort size 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2009-07-23
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-09-23
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2019-03-11
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2019-07-22
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2003-01-27
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2017-05-09

Official Correspondent

No official correspondent registered.

US Agent Details

Ivett Gagyi-Szabados Email: ivett.szabados@mambaby.com Phone: (914) 2692504

Related Public Records

Same Entity

MAM Baby AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012134276	Thaimed Hightech Co.,Ltd.	Kabinburi Prachin Buri, TH
3016245319	MAM Baby AG	Wollerau Schwyz, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008478778. Last updated year: 2026. Please use registration number 3008478778 when referencing this establishment in official correspondence.