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NycoCard READER II

by Abbott Diagnostics Technologies AS

Ref 1116815

NycoCard READER II (1116815) is a Class A device made by Abbott Diagnostics Technologies AS, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 7070060NYC0001GD), 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 Number7070060NYC0001GD Basic UDI-DI 07070060014210UDI-DIDate4 Nov 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  • Withdrawn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

Model / reference
1116815
Primary DI / UDI-DI
07070060014210
Basic UDI-DI
7070060NYC0001GD
EMDN code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device class
Class A
EU registration type
Standard device
EU market of registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000001423

Similar devices in this category

Other devices filed under VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER.

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Properties

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