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Sanctuary Health Sdn. Bhd.

Malaysia · Ipoh · www.sanctband.com/www.sanctband-active.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN MY-MF-000002197

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 9 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

50UDI-DI device records

Class I 50

USUnited StatesFDA openFDA

10listed device types

Class I 9Class II 1Class III 0

plus 10 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

24registered device records

Class I 24

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

21active ARTG entries

Class I 21

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 3

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.

European Union50 raw hits, 0 excluded, 50 confirmed

United States10 registration records, 1 510(k), 0 PMA

United Kingdom24 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Manufacturer names merged into this page: SANCTUARY HEALTH SDN BHD · SANCTUARY DENTAL BY SANCTUARY HEALTH SDN BHD · SANCTUARY HEALTH SDN. BHD. · Sanctuary Health Sdn Bhd

Regulatory identity

EU manufacturer SRN: MY-MF-000002197
EU authorised representative: Wellkang Ltd
UK responsible person: Wellkang Ltd

FDA 510(k) clearances by year

12022 · K212037

FDA listed device types

showing 8 of 10

Exerciser, Non-Measuring 1Frame, Rubber Dam 1Clamp, Rubber Dam 1Forceps, Rubber Dam Clamp 1Retractor, All Types 1Dental Prophylaxis Kit 1Dam, Rubber 1Handle, Instrument, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09555514016692	ComfiTract Latex Free Cheek Retractor 75mm (Medium)	Class I
EU	09555514016685	ComfiTract Latex Free Cheek Retractor 85mm (Large)	Class I
EU	09555514016012	ComfiTract Latex Free Cheek Retractor 85mm (Large)	Class I
EU	09555514016029	ComfiTract Latex Free Cheek Retractor 75mm (Medium)	Class I
UK	41158	Balance ball exerciser	Class I
UK	34181	Body elastic exerciser	Class I
UK	63315	COMFITRACT LATEX-FREE CHEEK RETRACTOR	Class I
US	K212037	SancDam Latex Oral Dam	2022-03-28
BR	80666970001	LENÇOL DE BORRACHA K-DENT	Class II
BR	10330660217	TUBO DE LÁTEX DESCARPACK IV	Class I
BR	80801630022	Lençol de Borracha AllPrime	Class I
SA	ME0000005570SFDAA00002	Dental dam	—
SA	ME0000005570SFDAA00001	Sanctuary Dental Dams	—

Sanctuary Health Sdn. Bhd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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