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i-STAT 1 Printer Kit

by Abbott Point of Care Inc.

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

Ref 04P74-04

i-STAT 1 Printer Kit (04P74-04) 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 00054749000333UDI-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  • Withdrawn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
04P74-04
Primary DI / UDI-DI
00054749000333
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.

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Properties

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