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MaxVenturi R211P03-019

by Maxtec, Inc.

Ref R211P03-019

MaxVenturi R211P03-019 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 081777002MAXVENTURIFV), cleared under FDA 510(k) K063488 on 22 Feb 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817770020981), 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) K063488

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 Number081777002MAXVENTURIFV Basic UDI-DI 00817770020981UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817770020981 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063488 Date22 Feb 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081777002MAXVENTURIFV registered 27 Oct 2026 Active
  • FDA 510(k) K063488 decided 22 Feb 2007 Active
  • FDA GUDID UDI-DI 00817770020981 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K063488
  2. Listed FDA GUDID 00817770020981
  3. Registered EUDAMED 081777002MAXVENTURIFV

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  • Withdrawn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
Maxventuri with Max-250 Ext. Series and Diss Fitting EUDAMED
MaxVenturi GUDID
Generic name
Respiratory oxygen monitor, battery-powered
Model / reference
R211P03-019
Primary DI / UDI-DI
00817770020981
Basic UDI-DI
081777002MAXVENTURIFV
Direct marketing DI
00817770020981
510(k) Number
FDA product code
CCL
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Respiratory oxygen monitor, battery-powered
Device class
Class IIa 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 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: Respiratory oxygen monitor, battery-powered

Cleared under the same submission (K063488)

and 8 more cleared under K063488

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)
  • Serial number
Other properties (23, all answered No)