Skip to content

WatchPAT™ONE

by Itamar Medical Ltd. 2 variants

Ref AC2111801

WatchPAT ONE (AC2111801), a polysomnograph (EU MDR Class IIa; FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Itamar Medical Ltd, was registered in EUDAMED on 24 Nov 2025 (Basic UDI-DI 729010922AC21508MX), cleared under FDA 510(k) K223675 on 6 Jan 2023 (1 earlier submission) and listed in FDA GUDID on 13 Mar 2023 (UDI-DI 07290109223254); registry data as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223675

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729010922AC21508MX Basic UDI-DI 07290109223254UDI-DIDate24 Nov 2025RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number07290109223254 UDI-DI Date13 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK223675 Date6 Jan 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729010922AC21508MX registered 24 Nov 2025 Active
  • FDA 510(k) K223675 decided 6 Jan 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290109223254 listed 13 Mar 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K183559
  2. Cleared FDA 510(k) K223675
  3. Listed FDA GUDID 07290109223254
  4. Registered EUDAMED 729010922AC21508MX

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  • Withdrawn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

Generic name
Polysomnograph
Model / Ref / Catalog
AC2111801, WatchPAT ONE (Canada)
Primary DI / UDI-DI
07290109223254
Basic UDI-DI
729010922AC21508MX
510(k) Number
FDA product code
MNR
EMDN code
Z12100501 Polysomnographs
GMDN term
Polysomnograph
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.2375
System or procedure pack
System which is a device in itself
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AC2111801
GUDID
WatchPAT ONE (Canada)
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.

Manufacturer details

EUDAMED SRN
IL-MF-000012046
Authorised representative
Arazy Group GmbH DE-AR-000007685

Similar devices in this category

Other devices filed under POLYSOMNOGRAPHS.

Other devices from Itamar Medical Ltd

See all devices from Itamar Medical Ltd →

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)