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ScaAI Patch

by SmartCardia SA

Ref 1007-L

ScaAI Patch (1007-L) is a device classified as Class IIa in the EU and Class II in the US made by SmartCardia SA, cleared under FDA 510(k) K240653 on 31 Oct 2024, registered in EUDAMED on 19 Sep 2023 (Basic UDI-DI B-07640375610041) and listed in FDA GUDID since 24 Apr 2026 (UDI-DI 07640375610041), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240653

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07640375610041 UDI-DI Date24 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240653 Date31 Oct 2024DecidedStatusActive
European UnionCE/MDD EUDAMED NumberB-07640375610041 Basic UDI-DI 07640375610041UDI-DIDate19 Sep 2023RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K240653 decided 31 Oct 2024 Active
  • EUDAMED Basic UDI-DI B-07640375610041 registered 19 Sep 2023 Active
  • FDA GUDID UDI-DI 07640375610041 listed 24 Apr 2026 Listed

Timeline

3 dated events

  1. Registered EUDAMED B-07640375610041
  2. Cleared FDA 510(k) K240653
  3. Listed FDA GUDID 07640375610041

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ScaAI Patch EUDAMED
SmartCardia 7L Platform GUDID
Generic name
General-purpose multi-parameter bedside monitor
Device name
ScaAI Patch Device
Model / reference
1007-L EUDAMED
1007L GUDID
Primary DI / UDI-DI
07640375610041
Basic UDI-DI
B-07640375610041
510(k) Number
FDA product code
QYX
EMDN code
C900399 Cardiovascular sensors - other
GMDN term
General-purpose multi-parameter bedside monitor
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1025
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1007-L
GUDID
1007L
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
CH-MF-000030647
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under CARDIOVASCULAR SENSORS.

Other devices from SmartCardia SA

Properties

  • Single use
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)