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Vapotherm Inc.

United States·US-MF-000006231

Last updated September 17, 2026

Information

Country: United States
Address: 100, Domain Drive, Exeter, United States
Website: www.Vapotherm.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-603-658-0011
PRRC Contact: Neeraj Pardhy
EUDAMED SRN: US-MF-000006231
FDA FEI Number: 3012971441
DUNS Number: —

Catalogue (408)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
Precision Flow® Disposable Patient Circuits and Accessories	TA-22	EUDAMED	Class IIa	Active
Precision Flow® Disposable Patient Circuits and Accessories	PF-STAND-D	EUDAMED	Class IIa	Active
Vapotherm	QSOFT-SOLO1700	FDA UDI	Class I	Active
Vapotherm	PF-VTU-DISS	FDA UDI	N/A	Active
Vapotherm	HVT-DPC	FDA UDI	Class II	Active
Vapotherm	PFH-PA-UKIT-EU	FDA UDI	N/A	Active
Vapotherm	HVT-UPGRADE-MODO	FDA UDI	Class II	Active
Vapotherm	OAM-MAS-UKIT-CA	FDA UDI	Class II	Active
Vapotherm	UNICORN-INF	EUDAMEDFDA UDI	Class I	Active
Vapotherm	MPS1500-PH	FDA UDI	Class II	Active
Vapotherm	OAM-NEL-UKIT-DK	FDA UDI	Class II	Active
Vapotherm	PF-Plus-UKIT-GB	FDA UDI	N/A	Active
Vapotherm	43000208	FDA UDI	Class II	Active
Vapotherm	PF-VTU-DISS-Rental	FDA UDI	N/A	Active
Vapotherm	HVT-UKIT-IL	FDA UDI	Class II	Active
Vapotherm	MI1300-BR	FDA UDI	Class I	Active
Vapotherm	QSOFT-MA1750	FDA UDI	Class I	Active
Vapotherm	PFH-UKIT-C-CA	FDA UDI	N/A	Active
Vapotherm	PROSOFT-INT-INF-PH	FDA UDI	Class II	Active
Vapotherm	PFH-UKIT-TR	FDA UDI	N/A	Active
Vapotherm	PFH-UKIT-C-ES	FDA UDI	N/A	Active
Vapotherm	PF-UKIT-US	FDA UDI	N/A	Active
Vapotherm	HVT 2.0MAS-UNIT	FDA UDI	Class II	Active
Vapotherm	HVT20-NEL	FDA UDI	Class II	Active
Vapotherm	HVT-ADPC-HIGH	FDA UDI	Class II	Active
Vapotherm	PF-OAMDPC-LOW	FDA UDI	Class II	Active
Vapotherm	PFH-PA-UKIT-GB	FDA UDI	N/A	Active
Vapotherm	PF-UKIT-FR	FDA UDI	N/A	Active
Vapotherm	OAM-MAS-UKIT-NO	FDA UDI	Class II	Active
Vapotherm	ProSoft-Pre	EUDAMEDFDA UDI	Class I	Active
Vapotherm	ProSoft-Ped-AS	EUDAMEDFDA UDI	Class I	Active
Vapotherm	MPS1500-Soft	FDA UDI	Class I	Active
Vapotherm	3003011-PH	FDA UDI	Class II	Active
Vapotherm	OAM-NEL-UKIT-NO	FDA UDI	Class II	Active
Vapotherm	MP1500	EUDAMEDFDA UDI	Class I	Active
Vapotherm	OAM-MAS-UKIT-MX	FDA UDI	Class II	Active
Vapotherm	MPS1500	EUDAMEDFDA UDI	Class I	Active
Vapotherm	PF-UKIT-DE	FDA UDI	N/A	Active
Vapotherm	MI1300B-IN	FDA UDI	Class I	Active
Vapotherm	AAA-1-PH	FDA UDI	Class II	Active
Vapotherm	PROSOFT-PED-AS-PH	FDA UDI	Class II	Active
Vapotherm	HiVNI-UKIT-DE	FDA UDI	Class II	Active
Vapotherm	MA1700-Soft	FDA UDI	Class I	Active
Vapotherm	HiVNI-UKIT-AR	FDA UDI	Class II	Active
Vapotherm	PF-DPC-HIGH-AJ5	FDA UDI	Class II	Active
Vapotherm	3003034-BR	FDA UDI	Class II	Active
Vapotherm	HiVNI-UKIT-PT	FDA UDI	Class II	Active
Vapotherm	PF-UKIT-RO	FDA UDI	N/A	Active
Vapotherm	AAA-1-BR	FDA UDI	Class II	Active
Vapotherm	PF-OAM-NEL	FDA UDI	Class II	Active

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 16, 2022	Z-1272-2023	—	open, classified	There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.
Aug 13, 2014	Z-2701-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Aug 13, 2014	Z-2703-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Aug 13, 2014	Z-2699-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Aug 13, 2014	Z-2706-2014	—	terminated	Water may leak into the center gas lumen of the Patient Circuit
Aug 13, 2014	Z-2700-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Aug 13, 2014	Z-2702-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Aug 13, 2014	Z-2705-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Aug 13, 2014	Z-2704-2014	—	terminated	Disposable Patient Circuit that allows water to leak into the center gas lumen
Oct 13, 2005	Z-0360-06	—	terminated	A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.