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259 device results listed.

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Access HBs Ab QC

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24298UE
Basic UDI-DI: B-A24298UE
Reference: A24298
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBs Ag QC

IVD Annex II List AIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A24294U6
Basic UDI-DI: B-A24294U6
Reference: A24294
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin/Haptoglobin Complex CONTROL MATERIAL

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313277070
Basic UDI-DI: B-86060313277070
Reference: C2035
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-H. Pylori Control

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060313276844
Basic UDI-DI: B-86060313276844
Reference: C2037
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:15

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems ETOH Calibrator

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-474994S4
Basic UDI-DI: B-474994S4
Reference: 474994
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 20:04

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 40 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472110PE
Basic UDI-DI: B-472110PE
Reference: 472110
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 10 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-472107PR
Basic UDI-DI: B-472107PR
Reference: 472107
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems DAT Drug Free Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-469945SF
Basic UDI-DI: B-469945SF
Reference: 469945
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

SYNCHRON Systems 75 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465912R4
Basic UDI-DI: B-465912R4
Reference: 465912
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems Level 2 Urine Protein Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465300PX
Basic UDI-DI: B-465300PX
Reference: 465300
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems Level 1 Urine Protein Control

IVD generalIVDDOn the marketHuman tissuesReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465290QM
Basic UDI-DI: B-465290QM
Reference: 465290
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450164NZ
Basic UDI-DI: B-450164NZ
Reference: 450164
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450163NX
Basic UDI-DI: B-450163NX
Reference: 450163
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level 1

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450162NV
Basic UDI-DI: B-450162NV
Reference: 450162
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Protein Control Level 3

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-450130NG
Basic UDI-DI: B-450130NG
Reference: 450130
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgM II QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34479H6
Basic UDI-DI: B-34479H6
Reference: 34479
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access HAV IgM QC

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34219GA
Basic UDI-DI: B-34219GA
Reference: 34219
EMDN: W0102152099
EMDN description: CONTROLS- 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

PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL

1 x 0.5ml

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Eurobio Scientific UK Ltd
Manufacturer SRN: UK-MF-000053721
UDI-DI: 25060527730155
Basic UDI-DI: B-25060527730155
Reference: PW85201
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 11.07.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHTROL™ TRYPTASE POSITIVE CONTROL

1 x 0.5ml

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Eurobio Scientific UK Ltd
Manufacturer SRN: UK-MF-000053721
UDI-DI: 25060527730148
Basic UDI-DI: B-25060527730148
Reference: PW85101
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 11.07.2026 15:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHTROL™ TRYPTASE HIGH POSITIVE CONTROL

5 x 0.5ml

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Eurobio Scientific UK Ltd
Manufacturer SRN: UK-MF-000053721
UDI-DI: 15060527730158
Basic UDI-DI: B-15060527730158
Reference: PW85205
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Norway
Authorised representative: MDSS GmbH
Last updated: 11.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details