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Changzhou Dsb Medical Co., Ltd.

China · Changzhou City Jiangsu

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 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

16listed device types

Class I 10Class II 6Class III 0

plus 17 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

2registered 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 States17 registration records, 1 510(k), 0 PMA

Saudi Arabia2 confirmed, 0 excluded

Manufacturer names merged into this page: CHANGZHOU DSB MEDICAL CO., LTD · CHANGZHOU DSB MEDICAL CO., LTD.

FDA 510(k) clearances by year

12021 · K211042

FDA listed device types

showing 8 of 16

Device, General Purpose, Microbiology, Diagnostic 1Cover, Cast 1Device, Incontinence, Urosheath Type, Non-Sterile 1Accessory, Surgical Apparel 1Micro Pipette 1Mask, Scavenging 1Container, Specimen Mailer And Storage, Non-Sterile 1System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile 1

Market	Identifier	Name	Class / date
US	K211042	Disposable Procedural Ear-loop Face Mask	2021-07-15
SA	ME0000001739SFDAA00002	Gentle-Sheath	—
SA	ME0000001740SFDAA00001	Gentle-Sheath	—

Changzhou Dsb Medical 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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