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Selectra ProM

by VitalScientific B.V. Netherlands EUDAMEDGUDID

Ref 6003-435Model 6003-404

Product code JGSEMDN W0201010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number37017008ProM-SeriesSL Basic UDI-DIDate28 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03701700860396 UDI-DIDate6 May 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

4 recalls · FDA

    • Terminated Z-2764-2019 FDA Class III initiated 12 Jul 2016 via K102647, on the same 510(k)

    Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

    • Terminated Z-0006-2015 FDA Class III initiated 11 Aug 2014 via K102647, on the same 510(k)

    Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.

  • 2 recalls, same reason

    • Terminated Z-0158-2020 FDA Class II initiated 10 Jan 2012
    • Terminated Z-0157-2020 FDA Class II initiated 10 Jan 2012

    The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Selectra ProM EUDAMED
Selectra GUDID
Generic Name
Multiple clinical chemistry analyser IVD, laboratory
Model / Ref / Catalog
6003-404, 6003-435, ProM
Primary DI / UDI-DI
03701700860396
Basic UDI-DI
37017008ProM-SeriesSL
510(k) Number
FDA Product Code
JGS
EMDN Code
W0201010105 CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.1665
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
6003-404
6003-435
GUDID
ProM
Device ClassEUDAMED
Class A
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000021018

Other devices from VitalScientific B.V.

See all devices from VitalScientific B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED a084939b-f543-4c1b-86a3-6c2ebddfdea7 61 fields · synced 22 Oct 2026
  • FDA UDI b49e4d39-005b-4b38-a0db-ef66aa50b1d8 34 fields · synced 30 May 2026