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Flow sensor 281637

by Hamilton Medical AG

Ref 281637

Flow sensor 281637 is a device classified as Class IIa in the EU and Class I in the US made by Hamilton Medical AG, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 76300028PN2816374Q) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 07630002800860), active as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number76300028PN2816374Q Basic UDI-DI Date17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630002800860 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 76300028PN2816374Q registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 07630002800860 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630002800860
  2. Registered EUDAMED 76300028PN2816374Q

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  • Withdrawn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
Flow sensor, 1.88 m, 15M x 15F/22M connectors EUDAMED
Flow sensor GUDID
Generic name
Breathing circuit gas-flow sensor, single-use
Model / reference
281637
Primary DI / UDI-DI
07630002800860, 17630002800867
Basic UDI-DI
76300028PN2816374Q
FDA product code
BYX
EMDN code
R9080 Respiratory and anesthesia devices - accessories not included in other classes
GMDN term
Breathing circuit gas-flow sensor, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5860
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa 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, single-use

Similar devices in this category

Other devices filed under RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Hamilton Medical AG

See all devices from Hamilton Medical AG →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)