Skip to content

Control Serum P

by Biotecnica Instruments S.r.l. Italy EUDAMED

Ref 482

EMDN W0101050101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08033622960515 Basic UDI-DIDate21 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
482
Primary DI / UDI-DI
08033622960515
Basic UDI-DI
B-08033622960515
EMDN Code
W0101050101 Assayed multicomponent controls (cc)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000008115

Other devices from Biotecnica Instruments S.r.l.

See all devices from Biotecnica Instruments S.r.l. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 08033622960515|B-08033622960515 61 fields · synced 24 Oct 2026