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REMISOL Advance

by Normand-Info S.A.S.U France EUDAMEDGUDID

Ref D27575, C88471Model Remisol Advance v.2.3

Product code JQPEMDN W02060182

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number15099590802073 UDI-DIDate17 Oct 2025ListedStatusIn distribution
European UnionCE/IVDR EUDAMED Number150995908RADVH4 Basic UDI-DIDate19 May 2022RegisteredStatusActive

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

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
REMISOL Advance EUDAMEDGUDID
REMISOL Advance v 2.3 EUDAMED
Generic Name
Clinical laboratory information system application software
Model / Ref / Catalog
Remisol Advance v.2.3, D27575, C88471, 2.4, 2.3
Primary DI / UDI-DI
15099590802073, 13700962601874
Basic UDI-DI
150995908RADVH4
FDA Product Code
JQP
EMDN Code
W02060182 Robotic sample processing systems - software accessories
GMDN Term
Clinical laboratory information system application software
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2100
Special Device Type
Software
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Remisol Advance v.2.3
D27575
C88471
GUDID
2.4
2.3
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
FR-MF-000024059

Other devices from Normand-Info S.A.S.U

Properties & raw data

Show properties, registry sources and raw records
  • Surgical Instrument
  • Premarket Exempt
Other properties (22)
  • 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
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (4)

  • EUDAMED 9c25dfb0-d537-4ead-9c2a-d525f403e7c8 61 fields · synced 22 Oct 2026
  • EUDAMED 13700962601874|150995908RADVH4 61 fields · synced 18 May 2026
  • FDA UDI 8e70abbc-4d0e-4411-a87b-04806ffadebc 34 fields · synced 23 Oct 2026
  • FDA UDI d6ca98f7-8452-434e-9309-5bdf30c779bb 34 fields · synced 23 Oct 2026