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06914329008613

IVD self-testing devicesNot specifiedNo longer on the market

Manufacturer: Beijing Yicheng Bioelectronics Technology Co., Ltd.
Manufacturer SRN: CN-MF-000033130
UDI-DI: 06914329008613
Basic UDI-DI: B-06914329008613
Reference: System（5DU-1）：113080006
EMDN: W020106019092
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: -
Authorised representative: Caretechion GmbH
Last updated: 01.08.2026 17:12

Manufacturer products Authorised representative products Authorised representative actors View details

Line Portal

Class IMDR 2017/745On the marketActive device

Manufacturer: Line Systems ApS
Manufacturer SRN: DK-MF-000031441
UDI-DI: 05745000980253
Basic UDI-DI: 5745000980LINESYSTEMS013H
Reference: v1.18.x
EMDN: W020106019082
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:41

Manufacturer products View details

WeCheck for S onyx

IVD Class AIVDR 2017/746On the market

Manufacturer: ARKRAY Factory, Inc.
Manufacturer SRN: JP-MF-000003008
UDI-DI: 04987486044604
Basic UDI-DI: 4987486BC0109504H6
Reference: 109504
EMDN: W020106019082
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: ARKRAY Europe, B.V.
Last updated: 31.07.2026 07:33

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

90 Sample Loader G8-90SL

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189238787
Basic UDI-DI: 45601892100040027H
Reference: 0021561
EMDN: W020106019080
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

myPatientSpace

Class IMDDOn the marketActive device

Manufacturer: myPatientSpace Limited
Manufacturer SRN: IE-MF-000042319
UDI-DI: 53915473600010
Basic UDI-DI: B-53915473600010
Reference: 1
EMDN: W020106019082
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Ireland
Authorised representative: -
Last updated: 17.07.2026 02:40

Manufacturer products 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

D-GP920VC

Rightest GP920

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Bionime Corporation
Manufacturer SRN: TW-MF-000008450
UDI-DI: D-GP920VC
Basic UDI-DI: B-GP920VC
Reference: GP920
EMDN: W020106019092
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 14.07.2026 00:42

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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

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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

Contour®

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Ascensia Diabetes Care Holdings AG
Manufacturer SRN: CH-MF-000034124
UDI-DI: D-3412481721220SN
Basic UDI-DI: B-3412481721220SN
Reference: 81721220
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Spain
Authorised representative: Ascensia Diabetes Care Italy Srl
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Contour®

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Ascensia Diabetes Care Holdings AG
Manufacturer SRN: CH-MF-000034124
UDI-DI: D-3412467075397L
Basic UDI-DI: B-3412467075397L
Reference: 6707539
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: Ascensia Diabetes Care Italy Srl
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Contour®

IVD Annex II List BIVDDOn the marketNear-patient testingSelf testing

Manufacturer: Ascensia Diabetes Care Holdings AG
Manufacturer SRN: CH-MF-000034124
UDI-DI: D-3412467075046Z
Basic UDI-DI: B-3412467075046Z
Reference: 6707504
EMDN: W020106019085
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - CONSUMABLES
First on market country: Finland
Authorised representative: Ascensia Diabetes Care Italy Srl
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors 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

OneTouch Reveal Web Application

OneTouch Reveal Web Application HCP

IVD generalIVDDNo longer on the marketProfessional testing

Manufacturer: LifeScan Europe GmbH
Manufacturer SRN: CH-MF-000014224
UDI-DI: 07613427030111
Basic UDI-DI: B-07613427030111
Reference: 024169
EMDN: W020106019092
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: LifeScan Deutschland GmbH
Last updated: 07.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details