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MAXBLEND2 R229P01-004

by Maxtec, Inc.

Ref R229P01-004

MAXBLEND2 R229P01-004 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 081777002MAXBLENDTW), cleared under FDA 510(k) K161718 on 27 Oct 2016 and listed in FDA GUDID since 9 Mar 2017 (UDI-DI 00817770021384), 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) K161718

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 Number081777002MAXBLENDTW Basic UDI-DI 00817770021384UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770021384 UDI-DI Date9 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161718 Date27 Oct 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081777002MAXBLENDTW registered 26 Oct 2026 Active
  • FDA 510(k) K161718 decided 27 Oct 2016 Active
  • FDA GUDID UDI-DI 00817770021384 listed 9 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161718
  2. Listed FDA GUDID 00817770021384
  3. Registered EUDAMED 081777002MAXBLENDTW

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  • Withdrawn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
MaxBlend2 LOW FLOW 0–30 LPM FLOWMETER NIST EUDAMED
MAXBLEND2 GUDID
Generic name
Oxygen/air breathing gas mixer, hospital
Device name
MaxBlend Air-Oxygen Blender (MaxBlend2 and MaxBlend Lite)
Model / reference
R229P01-004
Primary DI / UDI-DI
00817770021384
Basic UDI-DI
081777002MAXBLENDTW
Direct marketing DI
00817770021384
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 IIb 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 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: Oxygen/air breathing gas mixer, hospital

Cleared under the same submission (K161718)

and 8 more cleared under K161718

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

  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Measuring function
  • Serial number
Other properties (22, all answered No)