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R & G SEGURIDAD E HIGIENE INDUSTRIAL S.A.C.

Peru · Ventanilla Lima

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

9listed device types

Class I 7Class II 2Class III 0

plus 9 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States9 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: R & G SEGURIDAD E HIGIENE INDUSTRIAL S.A.C. · R&G SEGURIDAD E HIGIENE INDUSTRIAL S.A.C.

FDA 510(k) clearances by year

12024 · K232112

FDA listed device types

showing 8 of 9

Cap, Surgical 1Dress, Surgical 1Gown, Examination 1Non-Surgical Gown 1Helmet, Surgical 1Suit, Surgical 1Cover, Shoe, Operating-Room 1Mask, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232112	R&G Surgical Mask	2024-04-02
BR	82729690013	AVENTAL CIRÚRGICO ESTÉRIL SMS COM REFORÇO IMPERMEÁVEL MMED	Class I
BR	81665860002	Máscara Cirúrgica Descartável Tripla	Class I
BR	81665860003	EPIs Descartáveis	Class I

R & G SEGURIDAD E HIGIENE INDUSTRIAL S.A.C.

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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