Skip to content

i-STAT Electronic Simulator

by Abbott Point of Care Inc.

Part of a family of 6 devices: see the family page

Ref 06F11-01

i-STAT Electronic Simulator (06F11-01) is a Class A device made by Abbott Point of Care Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 0054749RQG0001K2), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0054749RQG0001K2 Basic UDI-DI 00054749000456UDI-DIDate24 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
i-STAT 1 Analyzers and Accessories
Model / reference
06F11-01
Primary DI / UDI-DI
00054749000456
Basic UDI-DI
0054749RQG0001K2
EMDN code
W0201010280 Limited panel chemistry analysers - hardware accessories
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000026231
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under LIMITED PANEL CHEMISTRY ANALYSERS.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Near-patient testing
  • Professional testing
  • IVD instrument
Other properties (10, all answered No)