UNIMOM CO.

Korea, Republic · Osan-Si Gyeonggi

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 2 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

5listed device types

Class I 4Class II 1Class III 0

plus 6 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States6 registration records, 4 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: UNIMOM CO.

FDA 510(k) clearances by year

12018 · K180075

12019 · K190810

12024 · K232047

12025 · K242111

FDA listed device types

Pump, Breast, Powered 1Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure 1Nipple, Lambs Feeding 1Pump, Breast, Non-Powered 1Shield, Nipple 1

Market	Identifier	Name	Class / date
US	K242111	VIVACE	2025-02-06
US	K232047	VIVACE	2024-03-28
US	K190810	OPERA, OPERA eco	2019-08-30
SA	ME0000004018SFDAA00001	Hygiene Manual Breast Pump	—

UNIMOM CO.

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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