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Across Gel

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

Ref 820101

Active European Union

CE IVDR

Valid until

6 Jul 2030

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number868019639TDAC1DN9 Basic UDI-DI 08680196390318UDI-DIDate24 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 795939 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    7 Jul 2025
    Expires
    6 Jul 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Across Rbc A1/B
Model / Reference
820101
Primary DI / UDI-DI
08680196390318
Basic UDI-DI
868019639TDAC1DN9
EMDN Code
W0103030101 Abo grouping cells
Device Class
Class D
EU market of registration
Italy

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