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Matrix Standard BT5 multi

by BIOTYPE GmbH

Ref 45-15100-0025, 45-15100-0050

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42519352MATRIXSTANDBT5M8U Basic UDI-DIDate28 Mar 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
45-15100-0025, 45-15100-0050
Primary DI / UDI-DI
04251935200751, 04251935200768
Basic UDI-DI
42519352MATRIXSTANDBT5M8U
EMDN Code
W0580 IVD general use consumables devices - other accessories
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025906

From the manufacturer

Manufacturer's product page: Matrix Standard BT5 multi

Other devices from BIOTYPE GmbH

See all devices from BIOTYPE GmbH →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No