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176 device results listed.

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HbA1c Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225939069
Basic UDI-DI: B-06971225939069
Reference: HBBZGH
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:30

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932251
Basic UDI-DI: B-06971225932251
Reference: HBBZ072
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

MR Urine Standard

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026503
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001690-00
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

MR Urine quality control

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904026510
Basic UDI-DI: 69449040BA80MRISE******JW
Reference: 105-001691-00
EMDN: W0101050302
EMDN description: URINE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:11

Manufacturer products Authorised representative products Authorised representative actors View details

β-HB Control

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904032382
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-002320-00
EMDN: W0101050302
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

β-Hydroxybutyrate (β-HB) Kit (Enzymatic Colorimetric Method)

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053400
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-004513-00
EMDN: W0101050302
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

β-Hydroxybutyrate (β-HB) Kit (Enzymatic Colorimetric Method)

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053417
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-004514-00
EMDN: W0101050302
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Unsaturated Iron Binding Capacity Kit (Colorimetric Method)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053424
Basic UDI-DI: 69449040004JUIBC*******XA
Reference: 105-004515-00
EMDN: W0101050302
EMDN description: IRON BINDING CAPACITY - TOTAL (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Unsaturated Iron Binding Capacity Kit (Colorimetric Method)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053431
Basic UDI-DI: 69449040004JUIBC*******XA
Reference: 105-004516-00
EMDN: W0101050302
EMDN description: IRON BINDING CAPACITY - TOTAL (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

β-Hydroxybutyrate (β-HB) Kit (Enzymatic Colorimetric Method)

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053783
Basic UDI-DI: 69449040004JB-HB*******Q2
Reference: 105-006184-00
EMDN: W0101050302
EMDN description: HYDROXYBUTYRATE DEHYDROGENASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Unsaturated Iron Binding Capacity Kit (Colorimetric Method)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904083247
Basic UDI-DI: 69449040004JUIBC*******XA
Reference: 105-009265-00
EMDN: W0101050302
EMDN description: IRON BINDING CAPACITY - TOTAL (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

ABX Pentra Micro ALB 2 Cal

1300032565

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008232
Basic UDI-DI: B-03610230008232
Reference: 1300032565
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:00

Manufacturer products View details

ABX Pentra TPU Cal

A11A01898

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005590
Basic UDI-DI: B-03610230005590
Reference: A11A01898
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra CO2 Cal

A11A01648

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005101
Basic UDI-DI: B-03610230005101
Reference: A11A01648
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

ABX Pentra RF Cal

A11A01618

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004845
Basic UDI-DI: B-03610230004845
Reference: A11A01618
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

STANDARD™ M10 Calibration Kit

M10-CAL-01

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111711350
Basic UDI-DI: 88001117IPAA01MA02W4
Reference: M10-CAL-01/11CAL10H
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ F Calibration Kit

FCAL-10

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

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111711213
Basic UDI-DI: 88001117IPAA01FA29V7
Reference: 10CAL10
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

CFΔ Collection System

CTL3

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000103
Basic UDI-DI: 86992260CTL3(130)YZ
Reference: CTL3
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

CFΔ Collection System

CAL90

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000073
Basic UDI-DI: 86992260CAL90RQ
Reference: CAL90
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details

CFΔ Collection System

CTL2

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: UTSAT SAĞLIK TEKNOLOJİLERİ SANAYİ TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000016643
UDI-DI: 08699226000097
Basic UDI-DI: 86992260CTL2(70)UP
Reference: CTL2
EMDN: W0101050302
EMDN description: CALIBRATORS SINGLE COMPONENT (CC)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 19:09

Manufacturer products View details