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LiteAire BASIC

by Thayer Medical Corporation

Ref 1803

LiteAire BASIC (1803) is a device classified as Class I in the EU and Class II in the US made by Thayer Medical Corporation, registered in EUDAMED on 20 Jun 2025 (Basic UDI-DI B-00383480000594) and listed in FDA GUDID since 11 Sep 2024 (UDI-DI 00383480000594), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00383480000594 Basic UDI-DI 00383480000594UDI-DIDate20 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00383480000594 UDI-DI Date11 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00383480000594 registered 20 Jun 2025 Active
  • FDA GUDID UDI-DI 00383480000594 listed 11 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00383480000594
  2. Registered EUDAMED B-00383480000594

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  • Withdrawn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

Generic name
Medicine chamber spacer, reusable
Device name
LiteAire BASIC Collapsible Dual Valved Holding Chamber
Model / Ref / Catalog
1803
Primary DI / UDI-DI
00383480000594
Basic UDI-DI
B-00383480000594
FDA product code
NVP
EMDN code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
GMDN term
Medicine chamber spacer, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5630
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000026197
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Gas-sampling/monitoring respiratory tubing, single-use

Similar devices in this category

Other devices filed under RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Thayer Medical Corporation

See all devices from Thayer Medical Corporation →

Properties

  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)