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HEMOSTASIS, LLC

USA · St. Paul

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 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

7listed device types

Class I 4Class II 2Class III 0unclassified 1

plus 9 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

9 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

TWTaiwanTFDA

4valid device licences

Class I 2Class III 2

SGSingaporeHSA SMDR

1device registrations

CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 States9 registration records, 10 510(k), 0 PMA, 2 excluded

Brazil6 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: HEMOSTASIS, LLC · HEMOSTASIS LLC

FDA 510(k) clearances by year

22007

12010

22012

12013

12015

22022

12024

FDA listed device types

Tube, Thorpe, Uncompensated 1Nasal Spray, Ent Delivery 1Splint, Intranasal Septal 1Balloon, Epistaxis 1Polymer, Ear, Nose And Throat, Synthetic, Absorbable 1Hemostatic Device For Endoscopic Gastrointestinal Use 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K234131	Resolv Endoscopic Hemostat System	2024-07-26
US	K220326	PosiSep X BAM Hemostat Dressing/Intranasal Splint	2022-11-14
US	K210411	PosiSep EAR Fragmentable Ear Dressing	2022-05-05
BR	80320689020	Vectra F	Class II
BR	80320680070	TAMPÃO HEMOSTÁTICO	Class II
BR	80320680072	NexFoam®esponja hemostatica	Class II
CA	81495	NEXFOAM TOPICAL HEMOSTAT SPONGE	Class II
CA	81826	NEXSTAT TOPICAL HEMOSTAT POWDER	Class II

HEMOSTASIS, LLC

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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