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28 device results listed.

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FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430225
Basic UDI-DI: 426242043GEN111SF
Reference: FR118
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

FR799

FR799-Identification of human specific ß-Actin

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430010
Basic UDI-DI: 426242043GEN222SR
Reference: FR799
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:32

Manufacturer products View details

D-IM4291315KU

HAV IgM Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291315KU
Basic UDI-DI: B-IM4291315KU
Reference: IM4291315
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

AdvanSure™ i3 TB-IGRA Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Invitros Co., Ltd
Manufacturer SRN: KR-MF-000023980
UDI-DI: D-IFR0002K00KN
Basic UDI-DI: B-IFR0002K00KN
Reference: IFR0002K00
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4283332HX

HSV-1/2 IgM Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283332HX
Basic UDI-DI: B-EIM4283332HX
Reference: EIM4283332
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4283328J8

HSV-2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283328J8
Basic UDI-DI: B-EIM4283328J8
Reference: EIM4283328
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4283327J6

HSV-1/2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283327J6
Basic UDI-DI: B-EIM4283327J6
Reference: EIM4283327
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4282332HQ

HSV-1/2 IgM Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4282332HQ
Basic UDI-DI: B-EIM4282332HQ
Reference: EIM4282332
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4282328HZ

HSV-2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4282328HZ
Basic UDI-DI: B-EIM4282328HZ
Reference: EIM4282328
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4282327HX

HSV-1/2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4282327HX
Basic UDI-DI: B-EIM4282327HX
Reference: EIM4282327
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4282323HP

Treponema Pallidum Antibody (anti-TP) Calibrators (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4282323HP
Basic UDI-DI: B-EIM4282323HP
Reference: EIM4282323
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4281332HH

HSV-1/2 IgM Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281332HH
Basic UDI-DI: B-EIM4281332HH
Reference: EIM4281332
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4281328HS

HSV-2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281328HS
Basic UDI-DI: B-EIM4281328HS
Reference: EIM4281328
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4281327HQ

HSV-1/2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281327HQ
Basic UDI-DI: B-EIM4281327HQ
Reference: EIM4281327
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4281323HG

Treponema Pallidum Antibody (anti-TP) Calibrators (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4281323HG
Basic UDI-DI: B-EIM4281323HG
Reference: EIM4281323
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:54

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgM, Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40706U2
Basic UDI-DI: B-A40706U2
Reference: A40706
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgG Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40703TU
Basic UDI-DI: B-A40703TU
Reference: A40703
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgG Calibrators

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A31589UJ
Basic UDI-DI: B-A31589UJ
Reference: A31589
EMDN: W0105080904
EMDN description: OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

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