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Ise Reference Solution

by VitalScientific 2 variants

Ref ISRS-0800

Ise Reference Solution (ISRS-0800) is an in vitro diagnostic device (EU IVDR Class A; EMDN category electrolyte electrode buffers and solutions) made by Vitalscientific, registered in EUDAMED on 11 Sep 2024 (Basic UDI-DI 37017008ISRS00F7) and listed in FDA GUDID since 31 Mar 2025 (UDI-DI 03701700824305), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03701700824305 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number37017008ISRS00F7 Basic UDI-DI 03701700824305UDI-DIDate11 Sep 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 37017008ISRS00F7 registered 11 Sep 2024 Active
  • FDA GUDID UDI-DI 03701700824305 listed 31 Mar 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 37017008ISRS00F7
  2. Listed FDA GUDID 03701700824305

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  • Withdrawn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

Generic name
Ion selective electrode (ISE) reference solution IVD, reagent
Model / reference
ISRS-0800
Primary DI / UDI-DI
03701700824305
Basic UDI-DI
37017008ISRS00F7
EMDN code
W0101070302 Electrolyte electrode buffers and solutions
GMDN term
Ion selective electrode (ISE) reference solution IVD, reagent
Device class
Class A
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FR-MF-000004722

Similar devices in this category

Other devices filed under ELECTROLYTE ELECTRODE BUFFERS AND SOLUTIONS.

Other devices from Vitalscientific

See all devices from Vitalscientific →

Properties

  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)