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TypeStream™ Visual Software version 3.2

by One Lambda, Inc.

Ref TSVPGRModel TSVPRG

TypeStream Visual Software version 3.2 (TSVPGR) is an in vitro diagnostic device (EU IVDR Class C; EMDN category micro-array instruments - IVD medical device software) made by One Lambda, Inc., registered in EUDAMED on 17 May 2026 (Basic UDI-DI 081469502TSVKN), 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 Number081469502TSVKN Basic UDI-DI 00814695024445UDI-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  • Withdrawn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
TypeStream™ Visual Software
Model / reference
TSVPRG, TSVPGR
Primary DI / UDI-DI
00814695024445
Basic UDI-DI
081469502TSVKN
Direct marketing DI
00814695024445
EMDN code
W02050292 Micro-array instruments - IVD medical device software
Device class
Class C
Special device type
Software
EU registration type
Standard device
EU market of registration
Austria

Manufacturer details

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

Similar devices in this category

Other devices filed under MICRO-ARRAY INSTRUMENTS.

Other devices from One Lambda, Inc.

See all devices from One Lambda, Inc. →

Properties

  • Professional testing
Other properties (12, all answered No)