Skip to content

EZ Collect Stool Nucleic Acid Collection and Preservation Device Dx

by Norgen Biotek Corporation

Ref Dx63730

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, self-declared

Class I: no certifier involved

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 Number++G226StoolNACPDEVQ3 Basic UDI-DI ++G226StoolNACPDEVQ6UDI-DIDate3 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
EZ Collect Stool Nucleic Acid Collection and Preservation Device Dx
Model / Reference
Dx63730
Primary DI / UDI-DI
++G226StoolNACPDEVQ6
Basic UDI-DI
++G226StoolNACPDEVQ3
Direct Marketing DI
++G226StoolNACPDEVQ6
EMDN Code
W05019001 Faeces collection devices
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CA-MF-000024034
Authorised representative
Emergo Europe B.V. NL-AR-000000116

From the manufacturer

Manufacturer's product page: Stool

Other devices from Norgen Biotek Corporation

See all devices from Norgen Biotek Corporation →

Properties

  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No