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Axis-Shield

by Axis-Shield Diagnostics Ltd 6 variants

Ref 2R10-35

Axis-Shield (2R10-35) is an in vitro diagnostic device (EU IVDR Class C; EMDN category bnp / probnp (including other natriuric peptides)) made by Axis-Shield Diagnostics Limited, registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 50558454NTP0004M9), active as of 23 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number50558454NTP0004M9 Basic UDI-DI 05055845400428UDI-DIDate20 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Alere NT-proBNP for ARCHITECT Reagent Kit
Model / reference
2R10-35
Primary DI / UDI-DI
05055845400428
Basic UDI-DI
50558454NTP0004M9
EMDN code
W01021301 Bnp / probnp (including other natriuric peptides)
Device class
Class C
EU registration type
Standard device
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000001886
Authorised representative
Abbott Rapid Dx International Limited IE-AR-000000091

Similar devices in this category

Other devices filed under BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES).

Other devices from Axis-Shield Diagnostics Limited

See all devices from Axis-Shield Diagnostics Limited →

Properties

  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)