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KetoBM KS-01

by Ketobm LLC

Ref 1320758Model KS-01

KetoBM KS-01 is a device classified as IVD for self-testing (EU), Class I (US) made by Ketobm LLC, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI B-00860182000645) and listed in FDA GUDID since 21 Nov 2022 (UDI-DI 00860182000645), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00860182000645 Basic UDI-DI 00860182000645UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00860182000645 UDI-DI Date21 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00860182000645 registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 00860182000645 listed 21 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00860182000645
  2. Registered EUDAMED B-00860182000645

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
KetoBM
Generic name
Ketone (acetoacetate) IVD, reagent
Device name
KetoBM Blood Ketone Test Strips
Model / reference
KS-01, 1320758
Primary DI / UDI-DI
00860182000645
Basic UDI-DI
B-00860182000645
FDA product code
JIN
EMDN code
W0101060110 Ketone test strips (β-hydroxybutyrate test strips)
GMDN term
Ketone (acetoacetate) IVD, reagent
Device class
Class IVD devices for self-testing EUDAMED
Class I GUDID
Regulation number
862.1435
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD devices for self-testing
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD devices for self-testing 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: Ketone (acetoacetate) IVD, reagent

Similar devices in this category

Other devices filed under KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS).

Other devices from Ketobm LLC

Properties

  • Single use
  • Contains substances of microbial origin
  • Reagent
  • Self-testing
  • Near-patient testing
  • Professional testing
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (14, all answered No)