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Bacticard R21106

by Remel, Inc.

Ref R21106

Bacticard R21106 is a device classified as Class A in the EU and Class I in the US made by Remel, Inc., registered in EUDAMED on 31 Mar 2026 (Basic UDI-DI 8488380BactiCardCandida8B) and listed in FDA GUDID since 23 Dec 2022 (UDI-DI 00848838022432), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8488380BactiCardCandida8B Basic UDI-DI 00848838022432UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00848838022432 UDI-DI Date23 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8488380BactiCardCandida8B registered 31 Mar 2026 Active
  • FDA GUDID UDI-DI 00848838022432 listed 23 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00848838022432
  2. Registered EUDAMED 8488380BactiCardCandida8B

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  • Withdrawn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
Bacticard Candida EUDAMED
Bacticard GUDID
Generic name
Bacterial species differentiation disc IVD
Model / Ref / Catalog
R21106
Primary DI / UDI-DI
00848838022432
Basic UDI-DI
8488380BactiCardCandida8B
FDA product code
JXB
EMDN code
W0104080203 Gram positive - manual identification
GMDN term
Bacterial species differentiation disc IVD
Device class
Class A 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 A
GUDID
Class I

Device class is stated on each registry's own scale: Class A 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: Bacterial species differentiation disc IVD

Similar devices

Also classified as Bacterial species differentiation disc IVD.

Similar devices in this category

Other devices filed under GRAM POSITIVE - MANUAL IDENTIFICATION.

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)