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Advancis Medical

United Kingdom of Great Britain and Northern Ireland · Kirby In Ashfield

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Hong Kong, Israel — 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

1510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class I 9Class II 6

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

20active device licences

Class II 20

TWTaiwanTFDA

8valid device licences

Class I 7Class II 1

SGSingaporeHSA SMDR

5device registrations

CLASS C 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

8valid listings

Class III 8

ILIsraelAMAR

7registrations

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 States0 registration records, 1 510(k), 0 PMA

Brazil15 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada20 confirmed, 1 excluded

Manufacturer names merged into this page: BRIGHTWAKE LIMITED ALSO TRADING AS ADVANCIS MEDICAL / SURGICAL · Advancis Medical · Brightwake Limited also trading as Advancis Medical and Advancis Surgical

Registration details (sample)

Market	Identifier	Name	Class / date
US	K101114	ADVANCIS ACTIVON TUBE	2011-07-26
BR	80301130016	ECLYPSE ADHERENT	Class II
BR	80301130017	Advasil Conform	Class I
BR	80301130027	SILTAPE	Class I
SA	ME0000013534SFDAA00030	Siltape	—
SA	ME0000013534SFDAA00028	Actibalm	—
CA	78494	ACTILITE	Class II
CA	78495	ACTIBALM	Class II
CA	78496	ACTIVON TUBE	Class II

Advancis Medical

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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