Home›China›Boen Healthcare Co., Ltd.

Boen Healthcare Co., Ltd.

China · Suzhou Jiangsu

✓ Record-verifiedregistrations found in 4 markets

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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

259listed device types

Class I 224Class II 35Class III 0

plus 258 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

18registered 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

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 States258 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia18 confirmed, 0 excluded

Manufacturer names merged into this page: BOEN HEALTHCARE CO., LTD. · Boen Healthcare Co., Ltd.,

FDA listed device types

showing 8 of 259

Urinary Drainage Collection Kit, For Indwelling Catheter 1Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) 1Electrode, Electrocardiograph 1Bottle, Collection, Vacuum 1Drape, Surgical, Exempt 1Apparatus, Suction, Operating-Room, Wall Vacuum Powered 1Trocar 1Light, Surgical, Accessories 1

Market	Identifier	Name	Class / date
BR	81333810004	Bandagem Adesiva Elástica Boenmed®	Class I
SA	ME0000008912SFDAA00008	DISPOSABLE VOMIT BAG	—
SA	ME0000008912SFDAA00014	TUBULAR BANDAGE	—

Boen Healthcare Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies