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DESCARTAVEIS NON WOVEN IMPORTAÇÃO E EXPORTAÇÃO LTDA.

Brazil

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

44listed device types

Class I 28Class II 15Class III 0unclassified 1

plus 146 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

149registered devices

Class I 148Class II 1

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

SASaudi ArabiaSFDA

96registered 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 States146 registration records, 13 510(k), 0 PMA, 3 excluded

Brazil149 confirmed, 0 excluded

Saudi Arabia96 confirmed, 0 excluded

Manufacturer names merged into this page: WUHAN LUCKY STAR NON WOVEN PRODUCTS CO LTD · HUBEI KANGCHENG NON-WOVEN CO., LTD · HUBEI XINXIN NON-WOVEN CO., LTD · Lianyungang Bronson Non-woven Products Co., Ltd. · XINYANG YIHE NON-WOVEN CO.,LTD · XIANTAO TONGDA NON-WOVEN PRODUCTS CO., LTD.

FDA 510(k) clearances by year

12005

12006

12019

32021

52022

12023

12026

FDA listed device types

showing 8 of 44

Cap, Surgical 1Gauze / Sponge,Nonresorbable For External Use 1Mask, Gas, Anesthetic 1Bedding, Disposable, Medical 1Operating Room Accessories Table Tray 1Absorber, Saliva, Paper 1Drape, Adhesive, Aerosol 1Bag, Ice 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253003	Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)	2026-04-20
US	K231510	Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)	2023-08-22
US	K211060	Disposable Surgical Gown Rk-3011C	2022-10-28
BR	82908660009	INNOVARE 3B AVENTAL CIRÚRGICO ESTÉRIL - SMMS	Class I
BR	82908660010	INNOVARE 3B AVENTAL CIRÚRGICO ESTÉRIL SMS	Class I
BR	81555530001	Máscara cirúrgica san camilo	Class I
SA	ME0000001165SFDAA00006	Innovative Non Woven Solutions L.L.C	—
SA	ME0000001165SFDAA00005	Innovative Non Woven Solutions L.L.C	—

DESCARTAVEIS NON WOVEN IMPORTAÇÃO E EXPORTAÇÃO LTDA.

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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