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Blood Glucose Control Solution

Level 1

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175027286
Basic UDI-DI: B-06934175027286
Reference: 1A003DD
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
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

saneo® SV-SC 01 Glucose Control Solution

Glucose Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 06424180100840
Basic UDI-DI: B-06424180100840
Reference: SV-SC 01
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Romania
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Glucose Control Solution

Glucose Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681925
Basic UDI-DI: B-04713945681925
Reference: 681.92
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Glucose Control Solution

Glucose Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681918
Basic UDI-DI: B-04713945681918
Reference: 681.91
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

EASYMAX® Glucose Control Solution

Glucose Control Solution

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 04713945681901
Basic UDI-DI: B-04713945681901
Reference: 681.90
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.08.2026 12:52

Manufacturer products Authorised representative products Authorised representative actors View details

STC

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Scienco Technology Corp.
Manufacturer SRN: TW-MF-000043119
UDI-DI: 04713616865067
Basic UDI-DI: B-04713616865067
Reference: 4713616865067
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.08.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

IME-DC

IVD Annex II List BIVDDOn the marketProfessional testingReagentSelf testing

Manufacturer: Scienco Technology Corp.
Manufacturer SRN: TW-MF-000043119
UDI-DI: 04713616862042
Basic UDI-DI: B-04713616862042
Reference: 4713616862042
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.08.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Solus V2 Glucose Control Solution

GCS

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: OK biotech co., Ltd
Manufacturer SRN: TW-MF-000028031
UDI-DI: 04712803568330
Basic UDI-DI: B-04712803568330
Reference: GCS
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

Linksun Blood Glucose Monitoring System

G-427B/G-427BS,G-425-2/G-425-2S,G-425-1/G-425S-1,G-426/G-425S-1,G-430/G-425S-1

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentKitReagentSelf testingSingle use

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184631486
Basic UDI-DI: 6939184630021BK
Reference: G-425-1/G-425S-1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Ireland
Safety summary (SSCP/SSP): IVDR-BL-BGMS-21 · Rev. A4
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:11

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

Glucose Control Solutions

Glucose control solution

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagentSelf testing

Manufacturer: Bioland Technology Ltd.
Manufacturer SRN: CN-MF-000010625
UDI-DI: 06939184600901
Basic UDI-DI: 6939184650001C3
Reference: 803GCS001990
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Malta
Safety summary (SSCP/SSP): IVDR-BL-BGMS-21 · Rev. A4
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:11

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

Blood Glucose Control Solution Level 1

Level 1

IVD Class CIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175030446
Basic UDI-DI: 6934175001C0102NW
Reference: 1A003
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Safety summary (SSCP/SSP): NPI052-SR-101 · Rev. A.2
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

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

Sinocare

Level 1, Level 2

IVD Class BIVDR 2017/746Not intended for EU marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009930
Basic UDI-DI: 6934175001C0501PG
Reference: REF 8C001, REF 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Sinocare

IVD Class BIVDR 2017/746On the marketNear-patient testingProfessional testingReagent

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175009947
Basic UDI-DI: 6934175001C0501PG
Reference: 8C002
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Control Solution Level 2

IVD Class CIVDR 2017/746On the marketDirect markingNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175030453
Basic UDI-DI: 6934175001C0102NW
Reference: 1A004
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: -
Safety summary (SSCP/SSP): NPI052-SR-101 · Rev. A.2
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:55

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

AccuSure Life Plus Control Solution

VGC02

IVD Annex II List BIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339211019
Basic UDI-DI: B-06937339211019
Reference: VGC02-0Y1
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Türkiye
Authorised representative: Lotus NL B.V.
Last updated: 28.07.2026 11:23

Manufacturer products Authorised representative products Authorised representative actors View details

Klinion Control solution

VGC02

IVD Annex II List BIVDDOn the marketKitReagentSelf testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210739
Basic UDI-DI: B-06937339210739
Reference: C047090
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 23.07.2026 23:50

Manufacturer products Authorised representative products Authorised representative actors View details

00860001641783

KBM-KCS

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

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 00860001641783
Basic UDI-DI: B-00860001641783
Reference: 1320770
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

04712558769037

eB-CS

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

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 04712558769037
Basic UDI-DI: B-04712558769037
Reference: 1220051
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 18.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C253NE

BF C25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C253NE
Basic UDI-DI: B-CNMF000014455-BF-C253NE
Reference: BF-C253
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-CNMF000014455-BF-C252NC

BF C25

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Wuxi Biohermes Bio & Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000014455
UDI-DI: D-CNMF000014455-BF-C252NC
Basic UDI-DI: B-CNMF000014455-BF-C252NC
Reference: BF-C252
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details