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Across Gel

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

Ref 830100

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 Number868019639TDSOL1C77 Basic UDI-DI 08680196390417UDI-DIDate12 Oct 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  • Withdrawn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
Across LISS
Model / Reference
830100
Primary DI / UDI-DI
08680196390417
Basic UDI-DI
868019639TDSOL1C77
Direct Marketing DI
08680196390417
EMDN Code
W0103030306 Enhancement media (e.g. bovine albumin, liss, peg)
Device Class
Class A
EU market of registration
Romania

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 D

  • Across Gel

    IVD General

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

Properties

  • Professional Testing

Other properties (10)

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