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Across Gel

by Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş. 4 variants

Ref 811209

Active European Union

CE IVDR

Valid until

29 Jul 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 Number868019639TDAG2DNY Basic UDI-DI 08680196390110UDI-DIDate11 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 795947 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jul 2026
    Expires
    29 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Across Gel Rh Phenotyping with Kell (K)
Model / Reference
811209
Primary DI / UDI-DI
08680196390110
Basic UDI-DI
868019639TDAG2DNY
EMDN Code
W0103030202, W0103030501
Device Class
Class D
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
TR-MF-000021449

Other devices from Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş.

See all devices from Di̇a Pro Tibbi̇ Ürünler San. Ve Ti̇c. A.Ş. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No