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Select 63748

by Bio-Rad

Ref 63748

Select 63748 is a device classified as Class B in the EU and Class I in the US made by Bio-Rad, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 361052A000277P) and listed in FDA GUDID since 5 Jan 2023 (UDI-DI 03610520002940), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A000277P Basic UDI-DI 03610520002940UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03610520002940 UDI-DI Date5 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361052A000277P registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 03610520002940 listed 5 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03610520002940
  2. Registered EUDAMED 361052A000277P

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  • Withdrawn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

Trade name
SaSelect EUDAMED
Select GUDID
Generic name
Differential/selective agar culture medium IVD
Device name
Chromogenic media for Staphylococcus aureus -Plates
Model / Ref / Catalog
63748
Primary DI / UDI-DI
03610520002940
Basic UDI-DI
361052A000277P
FDA product code
JSI
EMDN code
W0104010402 Chromogenic id media (plates)
GMDN term
Differential/selective agar culture medium IVD
Device class
Class B EUDAMED
Class I GUDID
Regulation number
866.2360
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

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

Related devices

Category: Differential/selective agar culture medium IVD

Similar devices in this category

Other devices filed under CHROMOGENIC ID MEDIA (PLATES).

Other devices from Bio-Rad

See all devices from Bio-Rad →

Properties

  • Single use
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)