Medela, Inc.

Switzerland · Mchenry

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

24listed device types

Class I 10Class II 14Class III 0

plus 82 registration records and 56 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 8Class II 6

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

20registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

19active device licences

Class II 18Class III 1

51 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

11device registrations

CLASS B 8CLASS C 3

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

44active ARTG entries

Class I 28IIa 12IIb 1Class Is (sterile) 3

HKHong KongMDACS

5valid listings

Class II 4Class III 1

ILIsraelAMAR

15registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 1Class 2a 4

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States82 registration records, 56 510(k), 0 PMA

Brazil14 confirmed, 2 excluded

Saudi Arabia20 confirmed, 1 excluded

Canada19 confirmed, 0 excluded

Manufacturer names merged into this page: MEDELA AG · MEDELA LLC · MEDELA, LLC · Medela AG

FDA 510(k) clearances by year

22003

22005

32006

12007

22008

12012

22013

22014

52015

32016

22017

32018

22019

12020

12021

12022

12023

12024

12025

32026

FDA listed device types

showing 8 of 24

Extractor, Vacuum, Fetal 1Negative Pressure Wound Therapy Powered Suction Pump 1Bottle, Collection, Vacuum 1Breast Pump Kit 1Pump, Breast, Powered 1System, Suction, Lipoplasty For Removal 1Enteral Syringes With Enteral Specific Connectors 1Syringe, Piston 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253510	Freestyle Mini Hands-free	2026-04-10
US	K253149	Motion InBra (YM-8801) wearable breast pump	2026-02-13
US	K253498	Pump In Style® Pro+	2026-01-22
BR	81480169001	EXTRATOR DE LEITE	Class II
BR	80102511430	Copos de Amostra Descartáveis Medela	Class I
BR	80102511432	FILTROS REUTILIZÁVEIS MEDELA	Class I
SA	ME0000005343SFDAA00001	Suction bag with solidifier	—
SA	ME0000005343SFDAA00002	Suction Bag	—
CA	60260	PUMP IN STYLE BREASTPUMP	Class II
CA	60261	MINIELECTRIC BREASTPUMP	Class II
CA	87389	MOTOR MINI ELECTRIC	Class II