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ULTRAMAXO2 R221P11-002

by Maxtec, Inc.

Ref R221P11-002

ULTRAMAXO2 R221P11-002 is a device classified as Class I in the EU and Class II in the US made by Maxtec, Inc., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 081777002ULTRAMAXO2K8), cleared under FDA 510(k) K112402 on 14 Dec 2011 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00817770020998), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K112402

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081777002ULTRAMAXO2K8 Basic UDI-DI 00817770020998UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770020998 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK112402 Date14 Dec 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081777002ULTRAMAXO2K8 registered 26 May 2026 Active
  • FDA 510(k) K112402 decided 14 Dec 2011 Active
  • FDA GUDID UDI-DI 00817770020998 listed 27 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112402
  2. Listed FDA GUDID 00817770020998
  3. Registered EUDAMED 081777002ULTRAMAXO2K8

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ULTRAMAXO2
Generic name
Respiratory oxygen monitor, battery-powered
Device name
UltraMax O2 Oxygen Analyzer
Model / reference
R221P11-002
Primary DI / UDI-DI
00817770020998
Basic UDI-DI
081777002ULTRAMAXO2K8
Direct marketing DI
00817770020998
510(k) Number
FDA product code
CCL
EMDN code
Z1203020403 Oxygen analysers
GMDN term
Respiratory oxygen monitor, battery-powered
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.1720
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K112402)

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Lot / batch number
Other properties (24, all answered No)