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Exdia PT10S

by Precision Biosensor Inc.

Ref PD-PT10S

Exdia PT10S (PD-PT10S) is a device classified as IVD for self-testing made by Precision Biosensor Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-08800026300434), active as of 7 Nov 2026.

Active European Union

CE IVDD

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/IVDD NumberB-08800026300434 Basic UDI-DI 08800026300434UDI-DIDate29 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device name
Exdia PT10S
Model / reference
PD-PT10S
Primary DI / UDI-DI
08800026300434
Basic UDI-DI
B-08800026300434
EMDN code
W0201010299 Limited panel chemistry analysers - other
Device class
Class IVD devices for self-testing
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000034861
Authorised representative
mdi Europa GmbH DE-AR-000006218

Similar devices in this category

Other devices filed under LIMITED PANEL CHEMISTRY ANALYSERS.

Other devices from Precision Biosensor Inc.

See all devices from Precision Biosensor Inc. →

Properties

  • Self-testing
  • Professional testing
  • IVD instrument
Other properties (9, all answered No)