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PGDx elio tissue complete

by Personal Genome Diagnostics, Inc. 2 variants

Ref B01102200

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0192721U0200100NL Basic UDI-DI 00192721001470UDI-DIDate8 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
B01102200
Primary DI / UDI-DI
00192721001470
Basic UDI-DI
0192721U0200100NL
Direct Marketing DI
00192721001470
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000026862
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Personal Genome Diagnostics, Inc.

See all devices from Personal Genome Diagnostics, Inc. →

Properties

  • Reagent
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No