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Alat Bm 100 / Bm 200

by BioMaxima Spółka Akcyjna

Ref 1-203-A075, 1-203-0060, 1-203-0300, 1-203-0150

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439BBCH203A7 Basic UDI-DI Date21 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Alat Bm 100 / Bm 200
Model / Reference
1-203-A075, 1-203-0060, 1-203-0300, 1-203-0150
Primary DI / UDI-DI
05902643961609, 05902643961579, 05902643961593, 05902643961586
Basic UDI-DI
59026439BBCH203A7
EMDN Code
W01010103 Alanine amino-transferase
Device Class
Class B
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

Related devices

Category: Alanine aminotransferase (ALT) IVD, reagent

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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