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Linksun Blood Glucose Monitoring System

-

IVD Class CNot specifiedOn the marketDirect markingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184632643
Basic UDI-DI: 6939184630021BK
Reference: G-430/G-425S-1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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

Linksun Blood Glucose Monitoring System

-

IVD Class CNot specifiedOn the marketDirect markingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184632650
Basic UDI-DI: 6939184630021BK
Reference: G-430/G-425S-1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
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 Glucose Control Solutions

GCD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005805
Basic UDI-DI: 8806712BGMCS007VM
Reference: 700026299
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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 Glucose Control Solutions

GCD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005799
Basic UDI-DI: 8806712BGMCS007VM
Reference: 700026278
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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 Glucose Control Solutions

GCD02

IVD Class CIVDR 2017/746On the marketProfessional testingReagentSelf testing

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005782
Basic UDI-DI: 8806712BGMCS007VM
Reference: 700026276
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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 Test Strips

GSD02

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

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005744
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026226
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 Test Strips

GSD02

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

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005720
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026225
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 Test Strips

GSD02

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

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005713
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026283
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 Test Strips

GSD02

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

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005706
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026282
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 Test Strips

GSD02

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

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005690
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026298
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 Test Strips

GSD02

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

Manufacturer: i-SENS, Inc.
Manufacturer SRN: KR-MF-000009173
UDI-DI: 08806712005683
Basic UDI-DI: 8806712BGMTS0083M
Reference: 700026227
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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 Glucose Control solution 3

BGC003

IVD Class CIVDR 2017/746On the marketReagentSelf testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701328
Basic UDI-DI: 88000767BGC0038K
Reference: BGC003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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

ConfiGlu G1 Glucose Control solution 2

BGC002

IVD Class CIVDR 2017/746On the marketReagentSelf testing

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076701106
Basic UDI-DI: 88000767BGC0028H
Reference: BGC002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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

ConfiGlu G1 Blood Glucose Test Strip

BGSG001

IVD Class CIVDR 2017/746On the marketReagentSelf testingSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700819
Basic UDI-DI: 88000767BGSG001FP
Reference: BGSG001
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

Płyn kontrolny do pomiaru stężenia glukozy we krwi VivaChek Fad

VGC02

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768697
Basic UDI-DI: B-06970221768697
Reference: VGC02-031
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
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

VivaChek Fad Blood Glucose Test Strips

VGS02

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221764132
Basic UDI-DI: B-06970221764132
Reference: VGS02-03A
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Fad Blood Glucose Test Strips

VGS02

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221764125
Basic UDI-DI: B-06970221764125
Reference: VGS02-032
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Fad Blood Glucose Test Strips

VGS02

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221763630
Basic UDI-DI: B-06970221763630
Reference: VGS02-038
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Ino Blood Glucose Test Strips

VGS01

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221763593
Basic UDI-DI: B-06970221763593
Reference: VGS01-019
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Ino Blood Glucose Test Strips

VGS01

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221763586
Basic UDI-DI: B-06970221763586
Reference: VGS01-014
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details