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30 device results listed.

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Access RUBELLA IgM CALIBRATORS

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34445GM
Basic UDI-DI: B-34445GM
Reference: 34445
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
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 HBc IgM (Reagent Pack)

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34250G4
Basic UDI-DI: B-34250G4
Reference: 34250
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
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

PlexPCR Colour Compensation

1.0

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000030
Basic UDI-DI: 9352224090001YK
Reference: 90001
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CMV Quant Assay Calibrator

Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514577
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05075
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 02.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV IgM Calibrator

C39448

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745134
Basic UDI-DI: 150995901C39448SE
Reference: C39448
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV Calibrator

C39445

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745103
Basic UDI-DI: 150995901C39445S8
Reference: C39445
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

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IGRA TB CS Elecsys

CalSet IGRA TB

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testingReagent

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 07613336224908
Basic UDI-DI: 761333602953BM
Reference: 09989960190
EMDN: W0105080901
EMDN description: BACTERIOLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Germany
Authorised representative: -
Last updated: 30.06.2026 12:50

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AutoLumo B19 IgM Calibrators

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177049
Basic UDI-DI: 697015090000276HT
Reference: CA170201
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo B19 IgG Calibrators

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06975577177018
Basic UDI-DI: 697015090000275HR
Reference: CA170101
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:16

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06937287300179

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300179
Basic UDI-DI: B-06937287300179
Reference: 6×1 mL (6 levels)
EMDN: W0105080907
EMDN description: MULTICONSTITUENT STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:51

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