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Spirolog Flow Sensor 8403735

by Drägerwerk AG & Co. KGaA

Ref 8403735Model 301011XK19P010

Spirolog Flow Sensor 8403735 is a breathing circuit gas-flow sensor (EU MDR Class IIb; FDA Class I; FDA product code BXP, Transducer, Gas Flow) made by Drägerwerk AG & Co. KGaA, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 040486751301011XK19P01029) and listed in FDA GUDID since 8 Apr 2022 (UDI-DI 04048675448860), active as of 12 Nov 2026.

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

CE MDR

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number040486751301011XK19P01029 Basic UDI-DI 04048675448860UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048675448860 UDI-DI Date8 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 040486751301011XK19P01029 registered 27 May 2026 Active
  • FDA GUDID UDI-DI 04048675448860 listed 8 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048675448860
  2. Registered EUDAMED 040486751301011XK19P01029

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Spirolog Flowsensor (5x) EUDAMED
Spirolog Flow Sensor GUDID
Generic name
Breathing circuit gas-flow sensor, reusable
Model / reference
8403735, 301011XK19P010
Primary DI / UDI-DI
04048675448860
Basic UDI-DI
040486751301011XK19P01029
Direct marketing DI
04048675448860
FDA product code
BXP
EMDN code
Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
GMDN term
Breathing circuit gas-flow sensor, reusable
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
868.2885
EU registration type
Standard device
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 I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Breathing circuit gas-flow sensor, reusable

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES.

Other devices from Drägerwerk AG & Co. KGaA

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Properties

  • Premarket exempt
  • Manufacturing date
Other properties (23, all answered No)