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Molnlycke Manufacturing US, LLC

USA · Wiscasset

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 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

6listed device types

Class I 5Class II 1Class III 0

plus 6 registration records and 27 510(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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

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, 27 510(k), 0 PMA, 13 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Molnlycke Manufacturing US, LLC · MOLNLYCKE MANUFACTURING US, LLC

FDA 510(k) clearances by year

12006

42007

12008

22011

12012

12013

12014

42015

62016

12019

32020

12021

12023

FDA listed device types

Protector, Skin Pressure 1Lift, Patient, Non-Ac-Powered 1Device, Transfer, Patient, Manual 1Dressing, Wound, Hydrophilic 1Bandage, Elastic 1Lift, Patient, 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

Molnlycke Manufacturing 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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