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HAOLANG MEDICAL USA CORPORATION

USA · Clyde Hill

✓ 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class III 0

plus 7 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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 States7 registration records, 3 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: HAOLANG MEDICAL USA CORPORATION

FDA 510(k) clearances by year

22021 · K201726

12025 · K241581

FDA listed device types

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1Catheter, Umbilical Artery 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Set, Administration, Intravascular 1Catheter, Percutaneous 1Catheter, Hemodialysis, Implanted 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241581	Hemodialysis Catheter	2025-05-16
US	K201726	Arterial Catheter	2021-07-07
US	K201697	Umbilical Vessels Catheter	2021-05-06
BR	81375039003	Cateter Arterial	Class II

HAOLANG MEDICAL USA CORPORATION

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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