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25 device results listed.

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06971771202631

EKS-101（25PCS）

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771202631
Basic UDI-DI: B-06971771202631
Reference: EKS-101（25PCS）
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 22.07.2026 23:57

Manufacturer products Authorised representative products Authorised representative actors View details

06935784440305

GUK S03

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784440305
Basic UDI-DI: B-06935784440305
Reference: GUK-S032
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 19.07.2026 07:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455GUK-S035LL

GUK S03

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455GUK-S035LL
Basic UDI-DI: B-CNMF000014455GUK-S035LL
Reference: GUK-S035
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455GUK-S031LC

GUK S03

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455GUK-S031LC
Basic UDI-DI: B-CNMF000014455GUK-S031LC
Reference: GUK-S031
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455GUK-S034LJ

GUK S03

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455GUK-S034LJ
Basic UDI-DI: B-CNMF000014455GUK-S034LJ
Reference: GUK-S034
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455GUK-S033LG

GUK S03

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455GUK-S033LG
Basic UDI-DI: B-CNMF000014455GUK-S033LG
Reference: GUK-S033
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-69750225319172CENSXR

Blood β-Ketone Test Strips

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: D-69750225319172CENSXR
Basic UDI-DI: B-69750225319172CENSXR
Reference: EN500R1、EN500R2、 EN500R3、 EN500R4
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

QUCARE® Pro beta-hydroxybutyrate test strip

QUCARE® Pro

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: DFI Co.,Ltd.
Manufacturer SRN: KR-MF-000015786
UDI-DI: D-KR-MF-000015786BHB9N
Basic UDI-DI: B-KR-MF-000015786BHB9N
Reference: 6022
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System

GM771

IVD Annex II List BIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GM771UW
Basic UDI-DI: B-GM771UW
Reference: 771K01
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

SANcheck ABEL β-Ketone Test Strip

BK-SK1

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BK-SK19S
Basic UDI-DI: B-BK-SK19S
Reference: BK-SK1
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

GlucoMen areo B-Ketone Sensor

IVD self-testing devicesIVDDOn the marketInstrumentMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSSketEFRL
Basic UDI-DI: B-8012992BGMSSketEFRL
Reference: 48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,48821,48530,48531
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

GLUCOFIX TECH B-Ketone Sensor

IVD Annex II List BIVDDOn the marketInstrumentMicrobial substancesNear-patient testingReagentSelf testingSingle use

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSSketEF2KQ
Basic UDI-DI: B-8012992BGMSSketEF2KQ
Reference: 48726 NL, 49911 FR, 50404 FR-E, 50415 FR, 48583 IT, 57171 UK-IT-FR
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: France
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

MultiSure GK

MultiSure GK blood ketone test strips

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487612AKT27
Basic UDI-DI: B-47136487612AKT27
Reference: S5640465, S5640466
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Poland
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KETOSURE POC Blood Ketone Test Strips

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609BKT3J
Basic UDI-DI: B-47136487609BKT3J
Reference: S5640894
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

KET-1

KET-1 Blood Ketone Monitoring System

IVD self-testing devicesIVDDNo longer on the marketInstrumentKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: D-47136487609A06R
Basic UDI-DI: B-47136487609A06R
Reference: S11004, S11008, S11009
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 11.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

FORA 6 𝝱-Ketone Test Strip

𝝱 Ketone Test Strip

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640402710324
Basic UDI-DI: B-07640402710324
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

FORA 6 𝝱-Ketone Test Strip

β-Ketone test strip

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143659074
Basic UDI-DI: B-07640143659074
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

FORA 6 𝝱-Ketone Test Strip

𝝱 Ketone Test Strip

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143658657
Basic UDI-DI: B-07640143658657
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

FORA 6 𝝱-Ketone Test Strip

𝝱-Ketone Test Strip

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143658008
Basic UDI-DI: B-07640143658008
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

FORA 6

𝝱-Ketone Test Strip

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 07640143653737
Basic UDI-DI: B-07640143653737
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details