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AMY - Amilasi / Amylase (CNPG3)

by Sanymed s.a.s. EUDAMED

Active European Union

Ref CCS631

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08056216730493 Basic UDI-DIDate9 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
AMY - Amilasi / Amylase (CNPG3) BT Line R1:5x20mL - 200 Test
Model / Reference
CCS631
Primary DI / UDI-DI
08056216730493
Basic UDI-DI
B-08056216730493
EMDN Code
W01010107 Amylase - total
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000026483

Other devices from Sanymed s.a.s.

See all devices from Sanymed s.a.s. →

Properties

  • 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