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Minispacer 1534

by Thayer Medical Corporation

Ref 1543

Minispacer 1534 (1543) is a device classified as Class IIa in the EU and Class II in the US made by Thayer Medical Corporation, registered in EUDAMED on 20 Dec 2024 (Basic UDI-DI B-00383480000259) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00383480000259), 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-00383480000259 Basic UDI-DI 00383480000259UDI-DIDate20 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00383480000259 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00383480000259 registered 20 Dec 2024 Active
  • FDA GUDID UDI-DI 00383480000259 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00383480000259
  2. Registered EUDAMED B-00383480000259

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  • Withdrawn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
Dual Spray MiniSpacer EUDAMED
Minispacer GUDID
Generic name
Metered dose inhaler
Device name
15mm OD/ID Dual Spray MiniSpacer
Model / Ref / Catalog
1543, 1534
Primary DI / UDI-DI
00383480000259
Basic UDI-DI
B-00383480000259
FDA product code
CAF
EMDN code
R020302 Respiratory circuits adapters and connectors
GMDN term
Metered dose inhaler
Device class
Class IIa 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1543
GUDID
1534
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.

Similar devices in this category

Other devices filed under RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS.

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Properties

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