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MAXFLO2 R223P08

by Maxtec, Inc.

Ref R223P08

MAXFLO2 R223P08 is a device classified as Class IIa in the EU and Class II in the US made by Maxtec, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 0853061002MAXFLOUK), cleared under FDA 510(k) K113232 on 1 Mar 2012 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00817770020806), 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) K113232

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 Number0853061002MAXFLOUK Basic UDI-DI 00817770020806UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770020806 UDI-DI Date27 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113232 Date1 Mar 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0853061002MAXFLOUK registered 27 Oct 2026 Active
  • FDA 510(k) K113232 decided 1 Mar 2012 Active
  • FDA GUDID UDI-DI 00817770020806 listed 27 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113232
  2. Listed FDA GUDID 00817770020806
  3. Registered EUDAMED 0853061002MAXFLOUK

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  • Withdrawn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
MAXFLO2 Mini 0-70 Lpm EUDAMED
MAXFLO2 GUDID
Generic name
Oxygen/air breathing gas mixer, hospital
Device name
MaxFlo2 Mini
Model / reference
R223P08
Primary DI / UDI-DI
00817770020806
Basic UDI-DI
0853061002MAXFLOUK
Direct marketing DI
00817770020806
510(k) Number
FDA product code
BZR
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Oxygen/air breathing gas mixer, hospital
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5330
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 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: Oxygen/air breathing gas mixer, hospital

Cleared under the same submission (K113232)

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Maxtec, Inc.

See all devices from Maxtec, Inc. →

Properties

  • Measuring function
  • Lot / batch number
Other properties (23, all answered No)