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ReLIA

Glycosylated Hemoglobin (HbA1c) Assay Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101900
Basic UDI-DI: B-06971354101900
Reference: RF16387-50T
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Slovenia
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:56

Manufacturer products Authorised representative products Authorised representative actors View details

ReLIA

Glycosylated Hemoglobin (HbA1c) Assay Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ReLIA Biotechnologies (Jiangsu), Inc.
Manufacturer SRN: CN-MF-000042042
UDI-DI: 06971354101481
Basic UDI-DI: B-06971354101481
Reference: RF16358-20T
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Slovenia
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

06952804837112

Blood β-Ketone Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804837112
Basic UDI-DI: B-06952804837112
Reference: C904005
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

06952804837099

Hemoglobin Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804837099
Basic UDI-DI: B-06952804837099
Reference: C905005
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

06952804824273

Blood Glucose Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804824273
Basic UDI-DI: B-06952804824273
Reference: C902005
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

06952804817879

Total Cholesterol Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817879
Basic UDI-DI: B-06952804817879
Reference: C906005
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598232507
Basic UDI-DI: B-06942598232507
Reference: FI-HBA-402
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE MLECZAN

TD-4663

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893238488
Basic UDI-DI: B-04719893238488
Reference: TD-4663
EMDN: W0101060104
EMDN description: LACTATE TEST STRIPS
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE KWAS MOCZOWY

TD-4653

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893236958
Basic UDI-DI: B-04719893236958
Reference: TD-4653
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE CHOLESTEROL

TD-4643

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893234800
Basic UDI-DI: B-04719893234800
Reference: TD-4643
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE B-KETONY

TD-4633

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893233933
Basic UDI-DI: B-04719893233933
Reference: TD-4633
EMDN: W0101060110
EMDN description: KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE GLUKOZA

TD-4370

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

Manufacturer: TaiDoc Technology Corporation
Manufacturer SRN: TW-MF-000017956
UDI-DI: 04719893233803
Basic UDI-DI: B-04719893233803
Reference: TD-4370
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

D48543

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180116
Basic UDI-DI: B-04260423180116
Reference: D48543
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Control Solution (Low)

D48537

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180062
Basic UDI-DI: B-04260423180062
Reference: D48537
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Test Strip

D48535

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180055
Basic UDI-DI: B-04260423180055
Reference: D48535
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Control Solution (Normal)

D48539

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180048
Basic UDI-DI: B-04260423180048
Reference: D48539
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

GluNEO Lite Blood Glucose Control Solution (High)

D48541

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260423180031
Basic UDI-DI: B-04260423180031
Reference: D48541
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:52

Manufacturer products Authorised representative products Authorised representative actors View details

SOMA® 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: 04260325295192
Basic UDI-DI: B-04260325295192
Reference: IS20201KT
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

FIABiomed Precisa Blood Glucose Test Strip

Precisa

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

Manufacturer: HMD Biomedical Inc.
Manufacturer SRN: TW-MF-000032809
UDI-DI: 04260236850824
Basic UDI-DI: B-04260236850824
Reference: 3L-10-350031
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Luana Med. B.V.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details

adia Blood Glucose Control Solution (High)

21515

IVD Annex II List BIVDDOn the marketReagentSelf testingSingle use

Manufacturer: OSANG Healthcare Co., Ltd
Manufacturer SRN: KR-MF-000032605
UDI-DI: 04260235110349
Basic UDI-DI: B-04260235110349
Reference: 21515
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 07:51

Manufacturer products Authorised representative products Authorised representative actors View details