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WatchPAT™ Central Plus Sensor

by Itamar Medical Ltd. 2 variants

Part of a family of 11 devices: see the family page

Ref AC3000115

WatchPAT Central Plus Sensor (AC3000115) is a polysomnograph (EU MDR Class IIa; FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Itamar Medical Ltd, registered in EUDAMED on 22 Jun 2023 (Basic UDI-DI 729010922AC21107M9), cleared under FDA 510(k) K222331 on 14 Sep 2022 (1 earlier submission) and listed in FDA GUDID since 13 Mar 2023 (UDI-DI 07290109223193), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222331

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729010922AC21107M9 Basic UDI-DI 07290109223193UDI-DIDate22 Jun 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number07290109223193 UDI-DI Date13 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK222331 Date14 Sep 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729010922AC21107M9 registered 22 Jun 2023 Active
  • FDA 510(k) K222331 decided 14 Sep 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290109223193 listed 13 Mar 2023 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K180775
  2. Cleared FDA 510(k) K222331
  3. Listed FDA GUDID 07290109223193
  4. Registered EUDAMED 729010922AC21107M9

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  • Withdrawn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

Trade name
WatchPAT™ Central Plus Sensor EUDAMED
Central Plus Sensor GUDID
Generic name
Polysomnograph
Device name
Watch-PAT300
Model / Ref / Catalog
AC3000115, Central Plus Sensor
Primary DI / UDI-DI
07290109223193
Basic UDI-DI
729010922AC21107M9
510(k) Number
FDA product code
MNR
EMDN code
Z12100580 Polysomnography instruments - hardware accessories
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
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AC3000115
GUDID
Central Plus Sensor
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 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Itamar Medical Ltd

See all devices from Itamar Medical Ltd →

Properties

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