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23 device results listed.

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00199150069439

MMT-8097W1

Class IIaMDR 2017/745On the marketNo EU rep

Manufacturer: Medtronic MINIMED
Manufacturer SRN: US-PR-000014565
UDI-DI: 00199150069439
Basic UDI-DI: 0763000B000344083
Reference: MMT-8097W2
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.08.2026 06:42

Manufacturer products View details

GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter (Full Set)

OG-PH05-HLM

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323056188
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HL-2
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 04.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO H Link Blood Glucose/Blood β-Ketone Test Meter (Meter Only)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323059486
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HLM
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

Cradle

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 08800323059462
Basic UDI-DI: 880911590OGPH05HLMG9
Reference: OG-PH05-HLR
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

SLX-121

SLX-121 Lipid and Blood Glucose Analyzer

IVD generalIVDDOn the marketInstrumentProfessional testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175039890
Basic UDI-DI: B-06934175039890
Reference: 3N001DD
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

KETOSURE POC

KETOSURE POC Blood Ketone Monitoring System

IVD Class AIVDR 2017/746On the market

Manufacturer: Apex Biotechnology Corp.
Manufacturer SRN: TW-MF-000019773
UDI-DI: 04713648764574
Basic UDI-DI: 47136487607B00KMbYP
Reference: M032
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

00199150069422

Class IIaNot specifiedOn the marketNo EU rep

Manufacturer: Medtronic MINIMED
Manufacturer SRN: US-PR-000014565
UDI-DI: 00199150069422
Basic UDI-DI: 0763000B000344083
Reference: MMT-8097W1
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 03:04

Manufacturer products View details

00199150038954

Class IIaNot specifiedOn the market

Manufacturer: Medtronic MINIMED
Manufacturer SRN: US-MF-000023100
UDI-DI: 00199150038954
Basic UDI-DI: 0763000B000327286
Reference: MMT-8600
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Medtronic B.V.
Last updated: 16.07.2026 03:04

Manufacturer products Authorised representative products Authorised representative actors View details

SANcheck ABEL GK Blood Glucose & β-Ketone Monitoring System

BC010D

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BC010DZ5
Basic UDI-DI: B-BC010DZ5
Reference: BC010D
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

PEMPA KETO Glucose & -Ketone Monitoring System

BC0100

IVD Annex II List BIVDDOn the marketInstrumentKitNear-patient testingProfessional testingSelf testing

Manufacturer: General Life Biotechnology Co., Ltd.
Manufacturer SRN: TW-MF-000027109
UDI-DI: D-BC0100XX
Basic UDI-DI: B-BC0100XX
Reference: BC0100
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 13.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

GLUCOFIX TECH GK

GLUCOFIX TECH GK Set

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

Manufacturer: A. MENARINI Diagnostics S.r.l.
Manufacturer SRN: IT-MF-000023427
UDI-DI: D-8012992BGMSMgluketUV2EP
Basic UDI-DI: B-8012992BGMSMgluketUV2EP
Reference: 52076 FR/IT, 52077 FR-basic, 52078 NL, 56815 UK, 57170 FR-basic-E, 57168 FR, 57169 FR-E
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 12.07.2026 09:30

Manufacturer products View details

16935784420267

GLU-A1C M24

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420267
Basic UDI-DI: B-16935784420267
Reference: GCA-M42
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784420250

GLU-A1C M14

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420250
Basic UDI-DI: B-16935784420250
Reference: GCA-M32
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784420243

GLU-A1C M22

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420243
Basic UDI-DI: B-16935784420243
Reference: GCA-M41
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

16935784420236

GLU-A1C M12

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingProfessional testingSelf testing

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 16935784420236
Basic UDI-DI: B-16935784420236
Reference: GCA-M31
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

ACCUGENCE®

PM800

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: e-LinkCare Meditech Co.,Ltd.
Manufacturer SRN: CN-MF-000019475
UDI-DI: 06971404131369
Basic UDI-DI: B-06971404131369
Reference: PM8002011
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

ACCUGENCE®

PM910

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: e-LinkCare Meditech Co.,Ltd.
Manufacturer SRN: CN-MF-000019475
UDI-DI: 06971404130904
Basic UDI-DI: B-06971404130904
Reference: PM9102014
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: Wellkang Ltd
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

Wielofunkcyjny Glukometr Szpitalny VivaChek Pro

VGM9802

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768703
Basic UDI-DI: 697022176VGM9802000226
Reference: VGM9802-725
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

06935784420260

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784420260
Basic UDI-DI: B-06935784420260
Reference: GCA-M42
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 15:06

Manufacturer products Authorised representative products Authorised representative actors View details

06935784420253

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: 06935784420253
Basic UDI-DI: B-06935784420253
Reference: GCA-M32
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 15:06

Manufacturer products Authorised representative products Authorised representative actors View details