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AUTOANALYZER MOD. MIURA 200 SA (44 Rgt Pos) p/n 11025-01-A

by I.S.E. - Societa' a Responsabilita' Limitata - Sistemi Intelligenti Elettronici

Ref I3320001202-E

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number803380351BCAAM200SA000173 Basic UDI-DI 08033803510263UDI-DIDate9 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier 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  • Withdrawn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

Device Name
Autoanalyzer Mod. Miura 200 SA
Model / Reference
I3320001202-E
Primary DI / UDI-DI
08033803510263
Basic UDI-DI
803380351BCAAM200SA000173
Direct Marketing DI
08033803510263
EMDN Code
W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
Device Class
Class A
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028898

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No