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SureFlow FM069-1

by Caire Inc.

SureFlow FM069-1 is a medical gas flowmeter (FDA Class I; FDA product code BXY, Flowmeter, Calibration, Gas) made by Caire Inc., registered in EUDAMED and listed in FDA GUDID since 27 Feb 2017 (UDI-DI M766FM06910), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberM766FM06910 UDI-DI Date27 Feb 2017ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI M766FM06910 listed 27 Feb 2017 Listed

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  • Withdrawn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
SureFlow
Generic name
Medical gas flowmeter, Thorpe tube
Model / reference
FM069-1
Primary DI / UDI-DI
M766FM06910
FDA product code
BXY
GMDN term
Medical gas flowmeter, Thorpe tube
Device class
Class I
Regulation number
868.2350
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code BXY (Flowmeter, Calibration, Gas).

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)