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Saline Solution

by Biomerieux SA 2 variants

Ref 542737

Saline Solution is a device classified as Class A in the EU and Class II in the US made by Biomerieux SA, registered in EUDAMED on 7 May 2026 (Basic UDI-DI 357302BUDI000916U6), listed under FDA premarket submission N50510 on 1 Aug 1979 and listed in FDA GUDID since 10 Feb 2022 (UDI-DI 03573026617950), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA N50510

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number357302BUDI000916U6 Basic UDI-DI 03573026617950UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03573026617950 UDI-DI Date10 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberN50510 Date1 Aug 1979DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 357302BUDI000916U6 registered 7 May 2026 Active
  • FDA premarket submission N50510 decided 1 Aug 1979 Active
  • FDA GUDID UDI-DI 03573026617950 listed 10 Feb 2022 Listed

Timeline

3 dated events

  1. Decided FDA premarket submission N50510
  2. Listed FDA GUDID 03573026617950
  3. Registered EUDAMED 357302BUDI000916U6

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Saline suspension medium/diluent IVD
Model / reference
542737 EUDAMED
SALINE SOLUTION GUDID
Primary DI / UDI-DI
03573026617950
Basic UDI-DI
357302BUDI000916U6
FDA product code
LON, LTW
EMDN code
W0203010185 Antibiotic susceptibility analysers - consumables
GMDN term
Saline suspension medium/diluent IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
866.1645, 866.1640
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
542737
GUDID
SALINE SOLUTION
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Saline suspension medium/diluent IVD

Cleared under the same submission (N50510)

and 8 more cleared under N50510

Similar devices in this category

Other devices filed under ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES.

Other devices from Biomerieux SA

See all devices from Biomerieux SA →

Properties

  • Supplied sterile
  • Reagent
  • Professional testing
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)