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SureTyper™

by One Lambda, Inc.

Ref STTPGRX

SureTyper (STTPGRX) is an in vitro diagnostic device (EU IVDR Class C) made by One Lambda, Inc., registered in EUDAMED on 17 May 2026 (Basic UDI-DI 081469502STPK8), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081469502STPK8 Basic UDI-DI 00814695024933UDI-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  • Withdrawn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
SureTyper Software
Model / reference
STTPGRX
Primary DI / UDI-DI
00814695024933
Basic UDI-DI
081469502STPK8
Direct marketing DI
00814695024933
EMDN code
W02050192 Nucleic acid testing instruments except micro-arrays - 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 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE.

Other devices from One Lambda, Inc.

See all devices from One Lambda, Inc. →

Properties

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