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Changzhou Holymed Products Co., Ltd.

China · Changzhou Jiangsu

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 11Class II 5Class III 0

plus 24 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0valid device licences

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 States24 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: CHANGZHOU HOLYMED PRODUCTS CO., LTD

FDA 510(k) clearances by year

22012 · K121998

12021 · K210524

FDA listed device types

showing 8 of 16

Gown, Surgical 1Drape, Surgical, Exempt 1Mask, Surgical 1Drape, Surgical, Antimicrobial 1General Surgery Tray 1Cap, Surgical 1Accessory, Surgical Apparel 1Brush, Scrub, Operating-Room 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K210524	Surgical Mask	2021-07-07
US	K121998	HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED	2012-12-20
US	K122000	HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER	2012-12-12

Changzhou Holymed Products 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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