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183 device results listed.

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Access HBc IgM QC

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34259GN
Basic UDI-DI: B-34259GN
Reference: 34259
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access RUBELLA IgG Calibrators

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34435GJ
Basic UDI-DI: B-34435GJ
Reference: 34435
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc IgM Calibrators

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34255GE
Basic UDI-DI: B-34255GE
Reference: 34255
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc Ab QC

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34249GK
Basic UDI-DI: B-34249GK
Reference: 34249
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc Ab Calibrators

IVD Annex II List AIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34245GB
Basic UDI-DI: B-34245GB
Reference: 34245
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access HAV IgM Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34215G2
Basic UDI-DI: B-34215G2
Reference: 34215
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access Digoxin Calibrator S0

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33716GN
Basic UDI-DI: B-33716GN
Reference: 33716
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Access Digoxin Calibrators

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33715GL
Basic UDI-DI: B-33715GL
Reference: 33715
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo sIgE Calibrators

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547352
Basic UDI-DI: 697015090000255HK
Reference: CA010302
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

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AutoLumo sIgE Calibrators

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547369
Basic UDI-DI: 697015090000255HK
Reference: CA010303
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

CLIA D-Dimer Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001201
Basic UDI-DI: B-06974521001201
Reference: CAL001
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

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ABX Pentra CRP HS Cal

A11A01983

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230005828
Basic UDI-DI: B-03610230005828
Reference: A11A01983
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 17:00

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K-ASSAY Multi-Analyte Calibrator

Multi-Analyte Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020566
Basic UDI-DI: B-00816426020566
Reference: KAI-016C
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

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QUANTA Flash PR3 Calibrators

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950554578
Basic UDI-DI: 84269505545789C
Reference: 701136
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

Evo Specific Standard G4

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154878
Basic UDI-DI: 8058945151N2000G42Z
Reference: 1N2000G4
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

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Evo Specific Standard G

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154830
Basic UDI-DI: 8058945151N2000GYG
Reference: 1N2000G
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

Evo Specific Standard E

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154748
Basic UDI-DI: 8058945151N2000Z6
Reference: 1N2000
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

MeMed BV® Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MeMed Diagnostics Ltd.
Manufacturer SRN: IL-MF-000023622
UDI-DI: 17290018739089
Basic UDI-DI: 729001873902CW
Reference: FG31001
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

CRP LATEX CALIBRATOR

CRP LATEX

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309123407
Basic UDI-DI: 5204309000019NX
Reference: 1478-0529
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

Access AMH Calibrators

B13128

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590665166
Basic UDI-DI: 150995903AccAMHCal43
Reference: B13128
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 11:49

Manufacturer products View details