Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016245319

FEI Number

3016245319

Entity Name

MAM Baby AG

City/State/Country

Wollerau Schwyz, CH

Establishment Address

Sihleggstrasse 15, Wollerau Schwyz 8832, CH

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) MAM Twister Preemie 1 MAM Comfort size 1 Preemie 2 MAM Perfect Pacifier MAM Comfort size 2 Massaging Brush Bite & Relax MAM Cooler, Mini Cooler, Bite & Play Bite & Brush Starter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2020-09-23
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2010-12-17
FNN	Nipple, Lambs Feeding	General Hospital	Class 1	880.5640	2017-05-09
JET	Pick, Massaging	Dental	Class 1	872.6650	2009-07-23
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2009-07-23
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2010-12-10
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2009-07-23

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
3008478778	MAM Hungária Kft.	Vaskeresztes, HU

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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Similar Registrations

Registration Number	Establishment Name	Location
3015200642	BABYATION INC.	Saint Louis, MO, US
3042823784	JMBH HOLDINGS LLC	Shelton, CT, US
3038613158	KIN YAT INDUSTRIAL (MALAYSIA) SDN. BHD.	Senai Johor, MY
3043515178	INTERFOCUS INC.	Mountain View, CA, US
3043165985	CHAFON TECHNOLOGY CO., LIMITED	TSIM SHA TSUI Hong Kong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016245319. Last updated year: 2026. Please use registration number 3016245319 when referencing this establishment in official correspondence.