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Biochemistry Calibrator

by Biosystems S.A.

Ref 18011

Biochemistry Calibrator (18011) is an in vitro diagnostic device (EU IVDR Class C; EMDN category calibrators multicomponent (cc)) made by Biosystems S.A., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 8435287140BIOCHCa00039), active as of 7 Nov 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8435287140BIOCHCa00039 Basic UDI-DI 08435287180114UDI-DIDate27 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Biochemistry Calibrator
Model / reference
18011
Primary DI / UDI-DI
08435287180114
Basic UDI-DI
8435287140BIOCHCa00039
EMDN code
W0101050301 Calibrators multicomponent (cc)
Device class
Class C
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000000231

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Biosystems S.A.

See all devices from Biosystems S.A. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
Other properties (9, all answered No)