Skip to content

Select 63751

by Bio-Rad

Ref 63751

Select 63751 is a device classified as Class C in the EU and Class II in the US made by Bio-Rad, registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 361052A000297T), cleared under FDA 510(k) K122187 on 6 Nov 2012 and listed in FDA GUDID since 16 Aug 2016 (UDI-DI 03610520002971), active as of 7 Nov 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122187

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number361052A000297T Basic UDI-DI 03610520002971UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03610520002971 UDI-DI Date16 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122187 Date6 Nov 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 361052A000297T registered 3 Nov 2026 Active
  • FDA 510(k) K122187 decided 6 Nov 2012 Active
  • FDA GUDID UDI-DI 03610520002971 listed 16 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122187
  2. Listed FDA GUDID 03610520002971
  3. Registered EUDAMED 361052A000297T

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VRESelect EUDAMED
Select GUDID
Generic name
Chromogenic VRE agar culture medium IVD
Device name
Chromogenic media for vancomycin-resistant Enterococcus -Plates
Model / Ref / Catalog
63751
Primary DI / UDI-DI
03610520002971
Basic UDI-DI
361052A000297T
510(k) Number
FDA product code
JSO
EMDN code
W0104010404 Chromogenic resistance marker media (plates) - mrsa, vre, esbl …
GMDN term
Chromogenic VRE agar culture medium IVD
Device class
Class C EUDAMED
Class II GUDID
Regulation number
866.1700
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 C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Chromogenic VRE agar culture medium IVD

Similar devices

Also classified as Chromogenic VRE agar culture medium IVD.

Similar devices in this category

Other devices filed under CHROMOGENIC RESISTANCE MARKER MEDIA (PLATES) - MRSA, VRE, ESBL ….

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
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)