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Mediplus A202Ax-M

by Mediplus, Ltd.

Ref A202Ax-M

Mediplus A202Ax-M is a device classified as Class IIa in the EU and Class II in the US made by Mediplus, Ltd., registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI B-05055140704009), cleared under FDA 510(k) K131339 on 25 Nov 2013 and listed in FDA GUDID since 19 Nov 2021 (UDI-DI 05055140704009), active as of 24 Oct 2026.

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

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K131339

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055140704009 Basic UDI-DI 05055140704009UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055140704009 UDI-DI Date19 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131339 Date25 Nov 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055140704009 registered 17 Aug 2026 Active
  • FDA 510(k) K131339 decided 25 Nov 2013 Active
  • FDA GUDID UDI-DI 05055140704009 listed 19 Nov 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131339
  2. Listed FDA GUDID 05055140704009
  3. Registered EUDAMED B-05055140704009

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  • Withdrawn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
Mediplus
Generic name
Capnography oxygen mask
Model / reference
A202Ax-M
Primary DI / UDI-DI
05055140704009
Basic UDI-DI
B-05055140704009
510(k) Number
FDA product code
CCK
EMDN code
R03010201 Air/oxygen masks
GMDN term
Capnography oxygen mask
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1400
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 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: Capnography oxygen mask

Cleared under the same submission (K131339)

and 8 more cleared under K131339

Similar devices in this category

Other devices filed under AIR/OXYGEN MASKS.

Other devices from Mediplus, Ltd.

See all devices from Mediplus, Ltd. →

Properties

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