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06975022535097

Blood Glucose and Uric Acid Meter

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

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: 06975022535097
Basic UDI-DI: 69750225319113CEMM
Reference: EN410
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

06975022535059

Blood Glucose and β-ketone Meter

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

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: 06975022535059
Basic UDI-DI: 69750225319112CEMG
Reference: EN510
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

06975022535011

Blood Glucose and Lactate Meter

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

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: 06975022535011
Basic UDI-DI: 69750225319111CEMB
Reference: EN310
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

06975022531037

IVD Class ANot specifiedOn the market

Manufacturer: EAGLENOS SCIENCES, INC.
Manufacturer SRN: CN-MF-000036801
UDI-DI: 06975022531037
Basic UDI-DI: 69750225323111CEKE
Reference: M424
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:54

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic HPLC HbA1c Analyzer

GSH-50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152362
Basic UDI-DI: 697122593GS3596862TX
Reference: GSH-50
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic HPLC HbA1c Analyzer

GSH-60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938970
Basic UDI-DI: 697122593GS35968EF
Reference: GSH-60
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Analyzer

A1c Go

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930127
Basic UDI-DI: 697122593GS35968AMV
Reference: A1c Go
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Meter

VOM01

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339206862
Basic UDI-DI: 697022176VOM0100001HF
Reference: VOM01-014
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

Automated HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641479
Basic UDI-DI: 69383846TY006XY
Reference: L-800504
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

POCT HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641448
Basic UDI-DI: 69383846TY004XU
Reference: L-800501
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

06933260212347

HLC-100

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212347
Basic UDI-DI: 69332602IT0100007A5
Reference: BT0000601
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

290 Sample Loader G8-290SL

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189238794
Basic UDI-DI: 45601892100040027H
Reference: 0021562
EMDN: W020106019080
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 01.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Meter

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184631530
Basic UDI-DI: 6939184630001BD
Reference: G-425-2
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Malta
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 01.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

mylife Aveo Blood Glucose Meter

GM02AAA

IVD Class CIVDR 2017/746On the marketInstrumentProfessional testingSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005676
Basic UDI-DI: 8806712BGMME006VX
Reference: 700026393
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Meter

GM02AAA

IVD Class CIVDR 2017/746On the marketInstrumentProfessional testingSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005652
Basic UDI-DI: 8806712BGMME006VX
Reference: 700026274
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005638
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026279
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005621
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026280
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005607
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026281
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

mylife Aveo Blood Glucose Monitoring System

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSelf testingSingle use

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005584
Basic UDI-DI: 8806712BGMS006T5
Reference: 700026203
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): IS-R2309-028 · Rev. Rev.4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 06:07

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ConfiGlu G1 Blood Glucose Meter Set

BGMGS001

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentSelf testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700833
Basic UDI-DI: 88000767BGMGS001PX
Reference: BGMGS001
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Germany
Safety summary (SSCP/SSP): GB-SSP-207 · Rev. 04
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details