Home›WRP ASIA PACIFIC SDN BHD

WRP ASIA PACIFIC SDN BHD

✓ Record-verifiedregistrations found in 11 marketsEU SRN MY-MF-000004690

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Israel, Russia — 11 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

297UDI-DI device records

Class I 158Class IIa 139

USUnited StatesFDA openFDA

12listed device types

Class I 10Class II 2Class III 0

plus 111 registration records and 46 510(k)

UKUnited KingdomMHRA PARD

17registered device records

Class I 6Class IIa 11

BRBrazilANVISA

7registered devices

Class I 5Class II 2

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

11 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

10active registrations

Class 1 1Class 2a 9

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 Union297 raw hits, 0 excluded, 297 confirmed

United States111 registration records, 46 510(k), 0 PMA, 3 excluded

United Kingdom17 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: WRP ASIA PACIFIC SDN. BHD. · WRP ASIA PACIFIC SDN BHD

Regulatory identity

EU manufacturer SRN: MY-MF-000004690
EU authorised representative: REMESCO HANDELSGESMBH
UK responsible person: Obelis UK Ltd
Exhibition record: CMEF 87th (Spring 2023, Shanghai)

FDA 510(k) clearances by year

21999

52000

52001

92002

52003

22004

12007

42009

12013

12014

12015

12016

12017

12020

12021

32022

22023

12024

FDA listed device types

showing 8 of 12

Surgeon'S Gloves 1Fentanyl And Other Opioid Protection Glove 1Radiographic Protective Glove 1Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs 1Polymer Patient Examination Glove 1Catheter, Balloon Type 1Medical Glove, Specialty 1Catheter, Irrigation 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	09557795018181	VÉLEZ GUANTES ESTERILES DE CIRUGIA Sensitivos Sin Polvo Libre de Látex NITRILO	Class IIa
EU	09557795018174	VÉLEZ GUANTES ESTERILES DE CIRUGIA Sensitivos Sin Polvo Libre de Látex NITRILO	Class IIa
EU	09557795018167	VÉLEZ GUANTES ESTERILES DE CIRUGIA Sensitivos Sin Polvo Libre de Látex NITRILO	Class IIa
EU	09557795018150	VÉLEZ GUANTES ESTERILES DE CIRUGIA Sensitivos Sin Polvo Libre de Látex NITRILO	Class IIa
UK	47172	NR Latex Examination Glove, Powder Free, Sterile	Class I
UK	47172	NR Latex Examination Glove, Powder Free, Non-sterile	Class I
UK	47172	Sterile powder free natural rubber latex examination gloves	Class I
US	K232079	Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl	2024-03-28
US	K232538	DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL	2023-11-17
US	K230578	Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl	2023-08-31
BR	82159190008	Luvas descartáveis	Class I
BR	81229600008	Luva para Procedimento Não Cirúrgico de nitrilo - sem pó - Bompack Med	Class I
BR	80605410022	luva cirúrgica em látex com pó talge	Class II
SA	ME0000005231SFDAA00008	Dermagrip Examination Gloves Classic	—
SA	ME0000005231SFDAA00009	Dermagrip Chemo Protection Gloves	—