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WEIHAI HONGYU MEDICAL DEVICES CO., LTD.

China · Weihai Shandong

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Australia, Israel, Russia — 5 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

39listed device types

Class I 32Class II 7Class III 0

plus 43 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

14registered devices

Class I 11Class 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

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

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 States43 registration records, 7 510(k), 0 PMA, 6 excluded

Brazil14 confirmed, 4 excluded

Saudi Arabia0 confirmed, 3 excluded

Manufacturer names merged into this page: Weihai Hongyu Nonwoven Fabric Products Co.,Ltd · WEIHAI HONGYU MEDICAL DEVICES CO., LTD.

FDA 510(k) clearances by year

12011 · K103587

12012 · K120192

12015 · K141324

22021 · K213029

22022 · K214088

FDA listed device types

showing 8 of 39

Gown, Surgical 1Wrap, Sterilization 1Clamp, Umbilical 1Respirator, Surgical 1Mask, Surgical 1Drape, Surgical, Antimicrobial 1Needle, Hypodermic, Single Lumen 1Cap, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K214088	Disposable Surgical Gown	2022-04-12
US	K220133	Sterilization Wraps	2022-03-10
US	K213029	Nitrile Examination Gloves (Powder free, Blue)	2021-12-14
BR	10379860112	TUBO PARA COLETA DE SANGUE COM ATIVADOR DE COÁGULO	Class I
BR	10379860111	TUBO PARA COLETA DE SANGUE COM REAGENTE	Class I
BR	10379860113	TUBO PARA COLETA DE SANGUE À VÁCUO PARA VHS	Class I

WEIHAI HONGYU MEDICAL DEVICES 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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