Skip to content

Pronto 9757

by Masimo Corporation

Ref 9757Model Pronto

Pronto 9757 is a device classified as Class IIb in the EU and Class II in the US made by Masimo Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00843997012393) and listed in FDA GUDID since 23 Sep 2019 (UDI-DI 00843997012393), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00843997012393 Basic UDI-DI 00843997012393UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843997012393 UDI-DI Date23 Sep 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00843997012393 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00843997012393 listed 23 Sep 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00843997012393
  2. Registered EUDAMED B-00843997012393

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Pronto
Generic name
Pulse Co-oximeter
Model / reference
9757, Pronto
Primary DI / UDI-DI
00843997012393
Basic UDI-DI
B-00843997012393
FDA product code
DQA
EMDN code
Z1203020408 Pulse oximeters
GMDN term
Pulse Co-oximeter
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Pulse Co-oximeter

Similar devices

Also classified as Pulse Co-oximeter.

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)