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P500 Clinical chemistry analyzer with ISE module

by Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság 2 variants

Ref P500-2Model Clinilcal Chemistry analyzers

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5999860094PCCRQ Basic UDI-DI 05999860094203UDI-DIDate1 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05999860094203 UDI-DI Date26 Jun 2018ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
P500 Clinical chemistry analyzer with ISE module EUDAMED
Pictus 500 Clinical chemistry analyzer GUDID
Generic Name
Multiple clinical chemistry analyser IVD, laboratory
Model / Ref / Catalog
Clinilcal Chemistry analyzers, P500-2, P500 clinical chemistry analyzer with ISE
Primary DI / UDI-DI
05999860094203
Basic UDI-DI
5999860094PCCRQ
FDA Product Code
JJE
EMDN Code
W0201010106 CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2160
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution
Size
Height — 820 Millimeter
Depth — 750 Millimeter
Width — 980 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Clinilcal Chemistry analyzers
P500-2
GUDID
P500 clinical chemistry analyzer with ISE
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
HU-MF-000020416

Other devices from Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

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Properties

  • Professional Testing
  • Surgical Instrument
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No