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Vapor 2000 M35054

by Drägerwerk AG & Co. KGaA

Ref M35054Model 228059

Vapor 2000 M35054 is a device classified as Class IIb in the EU and Class II in the US made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-04048675228059), cleared under FDA 510(k) K971923 on 16 Sep 1997 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 04048675228059), active as of 12 Nov 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K971923

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04048675228059 Basic UDI-DI 04048675228059UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675228059 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK971923 Date16 Sep 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04048675228059 registered 27 May 2026 Active
  • FDA 510(k) K971923 decided 16 Sep 1997 Active
  • FDA GUDID UDI-DI 04048675228059 listed 24 Oct 2015 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0933-2026 FDA Class I initiated 24 Nov 2025
    • Ongoing Z-0934-2026 FDA Class I initiated 24 Nov 2025

    A certain component of affected devices was not delivered within specification and contained impurities.

Timeline

5 dated events

  1. Cleared FDA 510(k) K971923
  2. Listed FDA GUDID 04048675228059
  3. Recall initiated FDA recalls Z-0933-2026
  4. Recall initiated FDA recalls Z-0934-2026
  5. Registered EUDAMED B-04048675228059

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vapor 2000
Generic name
Halothane anaesthesia vaporizer
Model / reference
M35054, 228059
Primary DI / UDI-DI
04048675228059
Basic UDI-DI
B-04048675228059
FDA product code
CAD
EMDN code
Z1203010101 Anaesthesia devices
GMDN term
Halothane anaesthesia vaporizer
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.5880
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Halothane anaesthesia vaporizer

Cleared under the same submission (K971923)

Similar devices in this category

Other devices filed under ANAESTHESIA DEVICES.

Other devices from Drägerwerk AG & Co. KGaA

See all devices from Drägerwerk AG & Co. KGaA →

Properties

  • Administering medicine
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)