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MOLNLYCKE HEALTH CARE (THAILAND), LTD.

Thailand · Amphur Muang Chonburi Chon Buri

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan — 5 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 103 registration records and 19 510(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

3valid device licences

Class I 3

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 States103 registration records, 19 510(k), 0 PMA, 8 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 Health Care Oy · Molnlycke Health Care AB · Molnlycke Health Care Sdn. Bhd. · MOLNLYCKE HEALTH CARE AB

Same-named companies — This database also contains companies with near-identical names: Molnlycke Health Care Sdn. Bhd., Molnlycke Health Care USA, Molnlycke/Scott Health Care. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21998

31999

32000

12003

22005

12006

12007

22010

22013

22014

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	K130852	AVANCE® FOAM ABDOMINAL DRESSING KIT	2014-04-14
US	K130040	MEPITEL AG	2014-02-12
US	K123892	MEPILEX TRANSFER AG	2013-04-05
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 (THAILAND), LTD.

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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