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RealTime

by Abbott Molecular Inc. 6 variants

Ref 09N02-001

RealTime (09N02-001) is a Class A device made by Abbott Molecular, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 0884999RTN0902BC), 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 Number0884999RTN0902BC Basic UDI-DI 00884999044074UDI-DIDate5 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  • Withdrawn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

Device name
Abbott mSample Preparation System DBS Buffer Kit
Model / reference
09N02-001
Primary DI / UDI-DI
00884999044074
Basic UDI-DI
0884999RTN0902BC
EMDN code
W0105900103 Supplemental na reagents
Device class
Class A
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000017776
Authorised representative
Abbott GmbH DE-AR-000009457

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Other devices filed under SUPPLEMENTAL NA REAGENTS.

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)