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Neo-200 AMYLASE

by PZ CORMAY Spółka Akcyjna Poland EUDAMED

Ref B08-R0004Model Neo-200 AMYLASE EMDN W01010107

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05907514600182 Basic UDI-DIDate17 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Amylase
Model / Reference
Neo-200 AMYLASE, B08-R0004
Primary DI / UDI-DI
05907514600182
Basic UDI-DI
B-05907514600182
EMDN Code
W01010107 Amylase - total
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000023053

Other devices from PZ CORMAY Spółka Akcyjna

See all devices from PZ CORMAY Spółka Akcyjna →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED dd853d64-0510-4ac6-a758-20c759f923c7 61 fields · synced 25 Oct 2026