Home›USA›Vantive US Healthcare, LLC

Vantive US Healthcare, LLC

USA · Deerfield

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia — 7 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

15listed device types

Class I 3Class II 11Class III 1

plus 58 registration records and 1 510(k), 31 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class I 1Class II 5

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

4 including historic records

TWTaiwanTFDA

5valid device licences

Class II 5

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 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 States58 registration records, 1 510(k), 31 PMA, 4 excluded

Brazil6 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Vantive US Healthcare LLC · VANTIVE US HEALTHCARE LLC

FDA 510(k) clearances by year

12025 · K250508

FDA listed device types

showing 8 of 15

Subsystem, Water Purification 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1Apparatus, Hemoperfusion, Sorbent 1Hemodialyzer With Expanded Solute Removal Profile 1Hemodialyzer, Re-Use, High Flux 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Dialysate Concentrate For Hemodialysis (Liquid Or Powder) 1Dialyzer, Capillary, Hollow Fiber 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250508	AK 98 Dialysis Machine (955607)	2025-08-01
BR	10068390005	EQUIPO DE TRANSFERENCIA DE 6' COM TWIST-CLAMP DE LONGA PERMANENCIA BAX	Class II
BR	10068390171	ADAPTADOR DE TITÂNIO BAXTER COM ROSCA PARA CATETER DE DIÁLISE PERITONE	Class II
BR	10068390201	EQUIPO CASSETE PARA DPA COM CICLADORA	Class II

Vantive US Healthcare, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies