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DoubleCHEK

by Enteral Access Technologies EUDAMED

Active European Union

Ref DC-1001

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-50606921900198 Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
DoubleCHEK DC-1001
Model / Reference
DC-1001
Primary DI / UDI-DI
50606921900198
Basic UDI-DI
B-50606921900198
EMDN Code
Z120704 Gastric ph monitor
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
UK-MF-000052150
Authorised representative
Advena Limited MT-AR-000000234

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No