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HI-FLOW Bubble humidifier 400cc, 6 psi

by Besmed Health Business Corp.

Ref HB-72650

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-HB-72650T5 Basic UDI-DI D-HB-72650T5UDI-DIDate4 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-HB-72650T5 UDI-DI Date13 Dec 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
HI-FLOW Bubble humidifier 400cc, 6 psi EUDAMED
HI-FLOW BUBBLE HUMIDIFIER 400cc (6 psi),DISPOSABLE GUDID
Generic Name
Room humidifier
Device Name
Disposable HI-FLOW Bubble humidifier 400cc, 6 psi
Model / Reference
HB-72650
Primary DI / UDI-DI
D-HB-72650T5 EUDAMED
04716770726502 GUDID
Basic UDI-DI
B-HB-72650T5
FDA Product Code
KFZ
EMDN Code
R060202 Oxygen administration humidification systems
GMDN Term
Room humidifier
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5460
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-HB-72650T5
GUDID
04716770726502
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
mdi Europa GmbH DE-AR-000006218

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No