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Across Gel

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

Ref 810233

Active European Union

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08680196391575 Basic UDI-DI 08680196391575UDI-DIDate24 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Across Gel Extended Monospecific Direct Coombs (EDAT)
Model / Reference
810233
Primary DI / UDI-DI
08680196391575
Basic UDI-DI
B-08680196391575
EMDN Code
W0103030399 Antibody detection (immunohaematology) - other
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TR-MF-000021449

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

  • Across Gel

    Class D

  • Across Aqua

    Class IIa

  • Across Gel

    Class D

  • Across Gel

    Class D

  • Across Gel

    Class A

  • Across Gel

    Class D

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

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

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