Skip to content

P500 Clinical chemistry analyzer

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

Active European Union

Ref P500-1-OModel Clinilcal Chemistry analyzers

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5999860094PCCRQ Basic UDI-DIDate1 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05999860094197 UDI-DIDate26 Jun 2018ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
P500 Clinical chemistry analyzer EUDAMED
Pictus 500 Clinical chemistry analyzer GUDID
Generic Name
Multiple clinical chemistry analyser IVD, laboratory
Model / Ref / Catalog
Clinilcal Chemistry analyzers, P500-1-O, P500 clinical chemistry analyzer W/out ISE module open
Primary DI / UDI-DI
05999860094197
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
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
P500-1-O
GUDID
P500 clinical chemistry analyzer W/out ISE module open
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

See all devices from Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag →

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