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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 3 of 9

Device	Model / Reference	Registries	Class	Status
Vapotherm	PFH-UKIT-C-MX	FDA UDI	N/A	Active
Vapotherm	HiVNI-UKIT-TH	FDA UDI	Class II	Active
Vapotherm	PF-DPC-HIGH2	FDA UDI	Class II	Active
Vapotherm	ProSoft-Inf	EUDAMEDFDA UDI	Class I	Active
Vapotherm	SOLO1300	EUDAMEDFDA UDI	Class I	Active
Vapotherm	PFH-UKIT-EU	FDA UDI	N/A	Active
Vapotherm	OAM-MAS-UKIT-CH	FDA UDI	Class II	Active
Vapotherm	HVT-BAT-BR	FDA UDI	Class II	Active
Vapotherm	PF-DPC-Low-WBA	FDA UDI	Class II	Active
Vapotherm	PF-DPC-LOW2	FDA UDI	Class II	Active
Vapotherm	HVT-STAND-GCX	FDA UDI	Class II	Active
Vapotherm	ProSoft-Adult	EUDAMEDFDA UDI	Class I	Active
Vapotherm	43000570	FDA UDI	Class II	Active
Vapotherm	UNICORN-ADULT	EUDAMEDFDA UDI	Class I	Active
Vapotherm	PF-OAM-NEL-UKIT-BR	FDA UDI	Class II	Active
Vapotherm	PLUS-UKIT-C-GB	FDA UDI	N/A	Active
Vapotherm	OAM-NEL-UKIT-DE	FDA UDI	Class II	Active
Vapotherm	3101134	FDA UDI	Class II	Active
Vapotherm	OAM-NEL-UKIT-IN	FDA UDI	Class II	Active
Vapotherm	MP1500-IN	FDA UDI	Class I	Active
Vapotherm	PF-Plus-UKIT-QA	FDA UDI	N/A	Active
Vapotherm	PF-DPC-LOW-KR	FDA UDI	Class II	Active
Vapotherm	MN1100B-PH	FDA UDI	Class II	Active
Vapotherm	FELIX-1	FDA UDI	N/A	Active
Vapotherm	PF-UKIT-ES	FDA UDI	N/A	Active
Vapotherm	PF-DPC-HIGH-KR	FDA UDI	Class II	Active
Vapotherm	PF-UKIT-CH	FDA UDI	N/A	Active
Vapotherm	PF-UNIT-FLM-IN	FDA UDI	Class II	Active
Vapotherm	PF-C-PLUS-FLM	FDA UDI	Class II	Active
Vapotherm	MI1300B	EUDAMEDFDA UDI	Class I	Active
Vapotherm	HiVNI-UKIT-MX	FDA UDI	Class II	Active
Vapotherm	PF-UKIT-NL	FDA UDI	N/A	Active
Vapotherm	OAM-NEL-UKIT-ES	FDA UDI	Class II	Active
Vapotherm	ProSoft-Int-Inf	FDA UDI	Class I	Active
Vapotherm	OAM-UKIT-IT	FDA UDI	Class II	Active
Vapotherm	HVT20-UNIT-VTU-DISS	FDA UDI	Class II	Active
Vapotherm	HiVNI-UKIT-PL	FDA UDI	Class II	Active
Vapotherm	PF-STAND-GCX	FDA UDI	Class I	Active
Vapotherm	PF-DPC-High-WBA	FDA UDI	Class II	Active
Vapotherm	PF-Plus-UKIT-NO	FDA UDI	N/A	Active
Vapotherm	HVT-VTU	FDA UDI	Class II	Active
Vapotherm	HVT20-NEL-FLM	FDA UDI	Class II	Active
Vapotherm	MA1700-IN	FDA UDI	Class I	Active
Vapotherm	PF-OAM-NEL-IN	FDA UDI	Class II	Active
Vapotherm	MN1100A-PH	FDA UDI	Class II	Active
Vapotherm	OAM-NEL-UKIT-AR	FDA UDI	Class II	Active
Vapotherm	OAM-NEL-UKIT-SE	FDA UDI	Class II	Active
Vapotherm	PF-Plus-UKIT-LB	FDA UDI	N/A	Active
Vapotherm	OAM-MAS-UKIT-TH	FDA UDI	Class II	Active
Vapotherm	OAM-UKIT-US	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.