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Safe-Accu2

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037438
Basic UDI-DI: B-06934175037438
Reference: 5D002DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
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

Safe-Accu

IVD Annex II List BIVDDOn the marketMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175037407
Basic UDI-DI: B-06934175037407
Reference: 1N003DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Spain
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

SG-12

SG-12 Blood Glucose Test Strip

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175033577
Basic UDI-DI: B-06934175033577
Reference: 3G003DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

LL-12

LL-12 Lipid Test Strip

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175033447
Basic UDI-DI: B-06934175033447
Reference: 3G002DD
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
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

Blood Glucose Control Solution

Level 2

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175027293
Basic UDI-DI: B-06934175027293
Reference: 1A004DD
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

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

Sinocare

Safe-Accu 2

IVD Annex II List BIVDDOn the marketInstrumentKitReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175023745
Basic UDI-DI: B-06934175023745
Reference: 6934175023745
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
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

Sinocare

Safe AQ pro Ⅰ

IVD Annex II List BIVDDOn the marketReagentSelf testing

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175016747
Basic UDI-DI: B-06934175016747
Reference: 5Y002DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
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

Sinocare

Safe AQ pro I

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

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: 06934175016594
Basic UDI-DI: B-06934175016594
Reference: 5Y001DD
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
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

Blood Glucose Test Strips

GO S1101 GL0810

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807612101
Basic UDI-DI: B-06921807612101
Reference: GL0810
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Ketone Test Strips

KT S1101 GL0625

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610275
Basic UDI-DI: B-06921807610275
Reference: GL0625
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

GO S1101 GL0825

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807610237
Basic UDI-DI: B-06921807610237
Reference: GL0825
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

Poctor 800

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesProfessional testingReagentSelf testingSingle use

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807602669
Basic UDI-DI: B-06921807602669
Reference: GL01poctor800
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 03.08.2026 05:00

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

saneo® SV-BT 01 Blood Glucose Test Strip

Glucose Test Strip

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesReagentSelf testingSingle use

Manufacturer: EPS Bio Technology Corp.
Manufacturer SRN: TW-MF-000028384
UDI-DI: 06424180100611
Basic UDI-DI: B-06424180100611
Reference: SV-BT 01
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
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

00860001641752

KBM-K01

IVD self-testing devicesIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Visgeneer Inc.
Manufacturer SRN: TW-MF-000036547
UDI-DI: 00860001641752
Basic UDI-DI: B-00860001641752
Reference: 1320757
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE β -KETONE TEST STRIPS

𝝱 Ketone Test Strip

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815597
Basic UDI-DI: B-05420040815597
Reference: ACS053
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE BLOOD GLUCOSE TEST STRIPS

Blood Glucose Test Strip

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815580
Basic UDI-DI: B-05420040815580
Reference: ACS046
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

4SURE BLOOD GLUCOSE TEST STRIPS

Blood Glucose Test Strip

IVD Annex II List BIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: ForaCare Suisse AG
Manufacturer SRN: CH-MF-000019906
UDI-DI: 05420040815573
Basic UDI-DI: B-05420040815573
Reference: ACS046
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 21:45

Manufacturer products Authorised representative products Authorised representative actors View details

Optinuvit Diabetes care Advance Plus Blood Glucose Test Strips TD-4335

IVD Annex II List BIVDDOn the marketInstrumentNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893239362
Basic UDI-DI: B-04719893239362
Reference: TD-4206
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.08.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details