ARDO MEDICAL AG

Switzerland · Unterageri

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel, Russia — 6 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

4listed device types

Class I 2Class II 2Class III 0

plus 8 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

5 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IIa 5Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 2Class 2b 2

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 States8 registration records, 6 510(k), 0 PMA

Saudi Arabia0 confirmed, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ARDO MEDICAL AG

FDA 510(k) clearances by year

12001 · K011601

12014 · K141742

12015 · K150721

12017 · K172067

12022 · K212773

12023 · K230590

FDA listed device types

Pump, Breast, Powered 1Pump, Portable, Aspiration (Manual Or Powered) 1Pump, Breast, Non-Powered 1Shield, Nipple 1

Market	Identifier	Name	Class / date
US	K230590	ARDO Bellis	2023-03-30
US	K212773	ARDO Alyssa	2022-04-15
US	K172067	One Mum Pumpset	2017-11-29
CA	98342	CARUM POWERED BREAST PUMP WITH BATTERY	Class II

ARDO MEDICAL AG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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