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softFlow 40630013

by Tni Medical AG

Ref 40630013

softFlow 40630013 is a device classified as Class IIa in the EU and Class II in the US made by Tni Medical AG, registered in EUDAMED on 8 May 2026 (Basic UDI-DI B-04059163000071) and listed in FDA GUDID since 15 Mar 2021 (UDI-DI 04059163000071), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04059163000071 Basic UDI-DI 04059163000071UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04059163000071 UDI-DI Date15 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04059163000071 registered 8 May 2026 Active
  • FDA GUDID UDI-DI 04059163000071 listed 15 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04059163000071
  2. Registered EUDAMED B-04059163000071

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  • Withdrawn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
Applicator Clinic Large EUDAMED
softFlow GUDID
Generic name
Inspiratory line humidification chamber, single-use
Model / Ref / Catalog
40630013
Primary DI / UDI-DI
04059163000071
Basic UDI-DI
B-04059163000071
FDA product code
BTT
EMDN code
R060202 Oxygen administration humidification systems
GMDN term
Inspiratory line humidification chamber, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5450
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Inspiratory line humidification chamber, single-use

Similar devices in this category

Other devices filed under OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS.

Other devices from Tni Medical AG

See all devices from Tni Medical AG →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)