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C1qScreen™

by One Lambda, Inc.

Ref C1Q

C1qScreen is an in vitro diagnostic device (EU IVDR Class C; EMDN category hla antibody screening) made by One Lambda, Inc., registered in EUDAMED on 17 May 2026 (Basic UDI-DI 081211701C1Q5J), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081211701C1Q5J Basic UDI-DI 00812117016658UDI-DIDate17 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
C1qScreen™ C1q
Model / reference
C1Q
Primary DI / UDI-DI
00812117016658
Basic UDI-DI
081211701C1Q5J
Direct marketing DI
00812117016658
EMDN code
W01030402 Hla antibody screening
Device class
Class C
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000024901
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)