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Molnlycke Health Care Us, LLC

USA · Norcross

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

20listed device types

Class I 14Class II 4Class III 0unclassified 2

plus 107 registration records and 47 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

1 including historic records

SASaudi ArabiaSFDA

50registered imported devices

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

CACanadaMDALL

16active device licences

Class II 14Class IV 2

67 including historic records

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 States107 registration records, 47 510(k), 0 PMA, 5 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia50 confirmed, 0 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: Molnlycke Health Care SDN BHD · Molnlycke Manufacturing US, LLC · Molnlycke Health Care Oy · Molnlycke Health Care AB · MOLNLYCKE HEALTH CARE AB

FDA 510(k) clearances by year

21998

31999

32000

12003

22005

22006

52007

12008

32010

22011

12012

32013

32014

42015

62016

12019

32020

12021

12023

FDA listed device types

showing 8 of 20

Cap, Surgical 1Protector, Skin Pressure 1Radiation Attenuating Medical Glove 1Mattress, Flotation Therapy, Non-Powered 1Surgeon'S Gloves 1Dressing, Wound, Occlusive 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Lift, Patient, Non-Ac-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232508	Barrier EasyWarm Active Self-Warming Blanket	2023-09-15
US	K203369	Avance Solo Negative Pressure Wound Therapy (NPWT) System	2021-07-01
US	K202090	Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim	2020-11-22
SA	ME0000000920SFDAA00007	Molnlycke BARRIER® Nurses Cap, Basic	—
SA	ME0000012208SFDAA00001	Barrier Scrub Suit	—
CA	5602	HYPERGEL	Class II
CA	6412	NORMLGEL	Class II
CA	9064	E-Z DERM BIOSYNTHETIC WOUND DRESSING	Class IV

Molnlycke Health Care Us, LLC

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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