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Karex Industries Sdn. Bhd.

Malaysia · Port Klang Selangor · www.karex.com.my

✓ Record-verifiedregistrations found in 12 marketsEU SRN MY-MF-000001247

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class IIa 49Class IIb 250Class III 1

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 28 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class IIa 4Class IIb 4Class III 1

BRBrazilANVISA

5registered devices

Class I 1Class II 4

28 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

4 including historic records

TWTaiwanTFDA

20valid device licences

Class II 20

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

9active ARTG entries

IIa 3IIb 5Class Is (sterile) 1

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 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.

European Union742 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States28 registration records, 8 510(k), 0 PMA

United Kingdom9 confirmed, 0 excluded

Brazil5 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: KAREX INDUSTRIES SDN BHD · KAREX INDUSTRIES SDN. BHD. · KAREX INDUSTRIES SDN, BHD

Regulatory identity

EU manufacturer SRN: MY-MF-000001247
EU authorised representative: Advena Limited
UK responsible person: Advena Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04260231450241	Amarelle Safety	Class IIb
EU	04260231450166	Amarelle Safety	Class IIb
EU	04260231450159	Amarelle Safety	Class IIb
EU	03160920960710	INTIMY Classic	Class IIb
UK	45138	Fair Squared Intense 10s	Class IIb
UK	45138	Boots Ultra Endurance, NRL Male Condom with Benzocaine Lubricant	Class IIb
UK	60608	Mediware Latex Probe Cover	Class IIa
US	K223519	Carex Hybrid Personal Lubricant	2023-08-11
US	K150743	Water Based Personal Lubricant with Flavours	2015-11-12
US	K141059	NATURAL RUBBER LATEX MALE CONDOMS	2014-08-01
BR	10208259003	PRUDENCE GEL SABORES	Class II
BR	10208250012	PRUDENCE GEL MORANGO FIRE	Class II
BR	10208250016	PRUDENCE GEL	Class II
CA	68873	LATEX CONDOMS	Class II
CA	84895	TRUSTEX LATEX CONDOMS	Class II

Karex Industries 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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