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LetsGetChecked Stool Sample Collection Kit (FCIT) FT01S

by Privapath Diagnostics Limited

Ref FT01I

LetsGetChecked Stool Sample Collection Kit (FCIT) FT01S is a device classified as Class A in the EU and Class I in the US made by Privapath Diagnostics Limited, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI 850024881SCT6) and listed in FDA GUDID since 4 May 2022 (UDI-DI 00850024881259), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number850024881SCT6 Basic UDI-DI 00850024881259UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850024881259 UDI-DI Date4 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 850024881SCT6 registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 00850024881259 listed 4 May 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850024881259
  2. Registered EUDAMED 850024881SCT6

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  • Withdrawn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
LetsGetChecked Stool Home Sample Collection Kit EUDAMED
LetsGetChecked Stool Sample Collection Kit (FCIT) GUDID
Generic name
Faecal specimen collection kit IVD, home-use
Model / Ref / Catalog
FT01I EUDAMED
FT01S GUDID
Primary DI / UDI-DI
00850024881259
Basic UDI-DI
850024881SCT6
FDA product code
NNK
EMDN code
W05019001 Faeces collection devices
GMDN term
Faecal specimen collection kit IVD, home-use
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.3250
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
FT01I
GUDID
FT01S
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: Faecal specimen collection kit IVD, home-use

Similar devices in this category

Other devices filed under FAECES COLLECTION DEVICES.

Other devices from Privapath Diagnostics Limited

See all devices from Privapath Diagnostics Limited →

Properties

  • Single use
  • IVD kit
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)