Skip to content

CP-2 Coagulation Control Plasma Level 2

by Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.

Ref Level-2

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 Number8680952301Level-2SM Basic UDI-DI 08680952301176UDI-DIDate3 Jul 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  • Withdrawn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

Model / Reference
Level-2
Primary DI / UDI-DI
08680952301176
Basic UDI-DI
8680952301Level-2SM
Direct Marketing DI
08680952301176
EMDN Code
W01040699 Controls, standards, calibrators, microbiology - other
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000021882

Other devices from Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.

See all devices from Sistat Tanı ve Tedavi Sistemleri Ltd. Şti. →

Properties

Other properties (11)

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