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Vapotherm HVT-DPC

by Vapotherm Inc.

Ref HVT-DPCModel HVT 2.0

Vapotherm HVT-DPC is a device classified as Class IIa in the EU and Class II in the US made by Vapotherm Inc., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 0841737102021UN) and listed in FDA GUDID since 3 Dec 2020 (UDI-DI 00841737103998), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841737102021UN Basic UDI-DI 00841737103998UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841737103998 UDI-DI Date3 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0841737102021UN registered 26 May 2026 Active
  • FDA GUDID UDI-DI 00841737103998 listed 3 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841737103998
  2. Registered EUDAMED 0841737102021UN

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Vapotherm
Generic name
Electrical mains power cable
Device name
Hvt 2.0
Model / reference
HVT-DPC, HVT 2.0
Primary DI / UDI-DI
00841737103998
Basic UDI-DI
0841737102021UN
Direct marketing DI
00841737103998
FDA product code
QAV, BTT
EMDN code
R040201 Tracheostomy humidifiers
GMDN term
Electrical mains power cable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5454, 868.5450
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Respiratory oxygen sensorElectrical mains power cableProfessional high-flow respiratory unit, humidifying, manual

Similar devices in this category

Other devices filed under TRACHEOSTOMY HUMIDIFIERS.

Other devices from Vapotherm Inc.

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Properties

  • Administering medicine
  • Convenience kit
Other properties (23, all answered No)