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Remel R8311004

by Remel, Inc.

Ref R8311004

Remel R8311004 is a device classified as Class B in the EU and Class I in the US made by Remel, Inc., registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 8488380RapIDSSuHN) and listed in FDA GUDID since 12 Nov 2021 (UDI-DI 00848838058110), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8488380RapIDSSuHN Basic UDI-DI 00848838058110UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838058110 UDI-DI Date12 Nov 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8488380RapIDSSuHN registered 20 Aug 2026 Active
  • FDA GUDID UDI-DI 00848838058110 listed 12 Nov 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838058110
  2. Registered EUDAMED 8488380RapIDSSuHN

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  • Withdrawn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
Rapid Ss/U System EUDAMED
Remel GUDID
Generic name
Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Model / reference
R8311004
Primary DI / UDI-DI
00848838058110
Basic UDI-DI
8488380RapIDSSuHN
FDA product code
JSS
EMDN code
W0104080299 Manual identification - other
GMDN term
Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid
Device class
Class B EUDAMED
Class I GUDID
Regulation number
866.2660
EU registration type
Standard device
EU market of registration
Netherlands
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: Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid

Similar devices in this category

Other devices filed under MANUAL IDENTIFICATION - OTHER.

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)