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Amylaza BM 100 / BM 200

by BioMaxima Spółka Akcyjna EUDAMED

Active European Union

Ref 1-213-A054

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number59026439CBCH213AT Basic UDI-DIDate21 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Amylaza BM 100 / BM 200
Model / Reference
1-213-A054
Primary DI / UDI-DI
05902643961678
Basic UDI-DI
59026439CBCH213AT
EMDN Code
W01010107 Amylase - total
Device Class
Class C
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000039473

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Properties

Show properties
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No