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MAXO2 Me R230P01

by Maxtec, Inc.

Ref R230P01

MAXO2 Me R230P01 is a device classified as Class IIb in the EU and Class II in the US made by Maxtec, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 0853061006MAXO2ME76), cleared under FDA 510(k) K153659 on 10 Jun 2016 and listed in FDA GUDID since 5 Jul 2016 (UDI-DI 00853061006951), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153659

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0853061006MAXO2ME76 Basic UDI-DI 00853061006951UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00853061006951 UDI-DI Date5 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153659 Date10 Jun 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0853061006MAXO2ME76 registered 26 Oct 2026 Active
  • FDA 510(k) K153659 decided 10 Jun 2016 Active
  • FDA GUDID UDI-DI 00853061006951 listed 5 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153659
  2. Listed FDA GUDID 00853061006951
  3. Registered EUDAMED 0853061006MAXO2ME76

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  • Withdrawn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
MaxO2ME EUDAMED
MAXO2 Me GUDID
Generic name
Respiratory oxygen monitor, line-powered
Model / Ref / Catalog
R230P01
Primary DI / UDI-DI
00853061006951
Basic UDI-DI
0853061006MAXO2ME76
Direct marketing DI
00853061006951
510(k) Number
FDA product code
CCL
EMDN code
Z1203020403 Oxygen analysers
GMDN term
Respiratory oxygen monitor, line-powered
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
868.1720
System or procedure pack
System which is a device in itself
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 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: Respiratory oxygen monitor, line-powered

Cleared under the same submission (K153659)

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)