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Hubei Xinxin Non-Woven Co., Ltd.

China · Xiantao Hubei

✓ 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 5Class II 5Class III 0

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 7

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 States11 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: HUBEI XINXIN NON-WOVEN CO., LTD · HUBEI XINXIN NON-WOVEN CO. LTD · HUBEI XINXIN NON-WONVE CO., LTD

FDA 510(k) clearances by year

32022 · K214116

12026 · K253003

FDA listed device types

showing 8 of 10

Cap, Surgical 1Accessory, Surgical Apparel 1Non-Surgical Gown 1Cover, Shoe, Operating-Room 1Bedding, Disposable, Medical 1Gown, Surgical 1Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection 1Gown, Isolation, Surgical 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	K214116	AAMI4 Isolation Gown	2022-10-11
US	K213832	AAMI3 Isolation Gown	2022-05-16
BR	80937150062	PROTECTCARE MÁSCARA CIRÚRGICA DESCARTÁVEL COM ELÁSTICO	Class I
BR	80937150057	SOL-M MÁSCARA CIRÚRGICA DESCARTÁVEL COM TIRAS	Class I
BR	80937150058	SOL-M MÁSCARA CIRÚRGICA DESCARTÁVEL COM ELÁSTICO	Class I

Hubei Xinxin Non-Woven Co., Ltd.

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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