Home›USA›Vapotherm, Inc.

Vapotherm, Inc.

USA · Exeter

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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 2Class II 4Class III 0

plus 10 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

11active device licences

Class II 11

26 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 2CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 1IIa 3IIb 1

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

4registrations

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 States10 registration records, 13 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: Vapotherm Inc. · VAPOTHERM, INC. · VAPOTHERM INC. · Vapotherm Inc

FDA 510(k) clearances by year

12000

12003

12004

12007

12008

22011

12018

12019

12021

22022

12026

FDA listed device types

High Flow/High Velocity Humidified Oxygen Delivery Device 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Bottle, Collection, Breathing System (Calibrated) 1Nebulizer (Direct Patient Interface) 1Regulator, Pressure, Gas Cylinder 1Cannula, Nasal, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254078	HVT 2.0	2026-04-13
US	K221318	HVT 2.0	2022-12-13
US	K220869	Vapotherm Aerosol Adapter AAA-2	2022-10-28
BR	80047309260	Família High Velocity Nasal Cannula	Class II
BR	80047309214	HVT 2.0 - Sistema de Terapia de Alta Velocidade	Class II
BR	80047309216	Aquecedor/umidificador de gases respiratórios do paciente	Class II
SA	ME0000010456SFDAA00019	Precision Flow Roll Stand	—
SA	ME0000010456SFDAA00020	Manifold Kit	—
CA	65962	VAPOTHERM 2000 I	Class II
CA	85619	INSOLARE NASAL CANNULA	Class II
CA	85839	FLOWGUARD INSULATED TUBE	Class II

Vapotherm, Inc.

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