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RFB LATEX Ltd.

✓ Record-verifiedregistrations found in 4 marketsEU SRN IN-MF-000004007

This company has registrations in European Union, United States, Brazil, Israel — 4 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

2UDI-DI device records

Class IIa 2

USUnited StatesFDA openFDA

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

3registered devices

Class II 3

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

2registrations

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.

European Union9 raw hits, 7 excluded, 2 confirmed

United States0 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: RFB LATEX LIMITED

Regulatory identity

EU manufacturer SRN: IN-MF-000004007
EU authorised representative: CMC Medical Devices & Drugs SL

Registration details (sample)

Market	Identifier	Name	Class / date
EU	+G442RSG27014500S	Surgitril	Class IIa
EU	+G442RSG27010500O	SurgiSens	Class IIa
US	K905161	RUBBER LATEX SURGICAL GLOVES, STERILE	1990-11-29
US	K895902	LATEX PATIENT EXAMINATION GLOVE	1990-02-13
BR	81359809002	LUVA CIRÚRGICA DE LÁTEX COM PÓ	Class II
BR	10341520005	Luva Cirúrgica Estéril New Hand Texturizada	Class II
BR	10341520006	Luva Cirúrgica Estéril Cirurgic Powder Free	Class II

RFB LATEX Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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