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MEDIVANCE, INC.

USA · Louisville

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

2listed device types

Class I 1Class II 1Class III 0

plus 6 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 3IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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, 12 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: MEDIVANCE, INC. · MEDIVANCE, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251974	Arctic Sun Temperature Management System (Model 5000)	2025-10-24
US	K243942	Arctic Sun Stat Temperature Management System	2025-04-30
US	K200225	Arctic Sun Stat Temperature Management System	2020-02-28
BR	80689090154	Arctic Sun Articgel Pads Neonatal (Almofadas Neonatais ArcticGel)	Class I
BR	80689090002	Arctic sun ArcticGel pads	Class I
BR	80689090242	Arctic Sun ArcticGel Pads Adulto	Class I

MEDIVANCE, INC.

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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