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AllType™ NGS Index Flex Kit

by One Lambda, Inc.

Ref ALL-FLEX

AllType NGS Index Flex Kit (ALL-FLEX) is an in vitro diagnostic device (EU IVDR Class C; EMDN category hla antigen typing) made by One Lambda, Inc., registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 081211701ALT7U), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081211701ALT7U Basic UDI-DI 00812117017761UDI-DIDate16 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
AllType™ NGS Amplification Kits
Model / reference
ALL-FLEX
Primary DI / UDI-DI
00812117017761
Basic UDI-DI
081211701ALT7U
EMDN code
W01030403 Hla antigen typing
Device class
Class C
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

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

Similar devices in this category

Other devices filed under HLA ANTIGEN TYPING.

Other devices from One Lambda, Inc.

See all devices from One Lambda, Inc. →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (8, all answered No)