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ADVIA Centaur HAV Total (aHAVT) Quality Control

IVDR_67_TTN_DUB-C_B_REAG_aHAVT_QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414481883
Basic UDI-DI: 0405686900759W7
Reference: 10322682
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Herpes-1 IgG (HSV1) Quality Control

IVDR_67_TTN_DUB-C_C_REAG_HSV1 QC

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414016757
Basic UDI-DI: 0405686901855WB
Reference: 10720847
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Herpes-2 IgG (HSV2) Quality Control

IVDR_67_TTN_DUB-C_C_REAG_HSV2 QC

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414016733
Basic UDI-DI: 0405686901856WD
Reference: 10720850
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima CMV Quant Assay Controls Kit

Aptima CMV Quant Assay

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045514584
Basic UDI-DI: 54200455DIAGAPTCMVAP
Reference: PRD-05076
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 17.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

08054320950158

IDS Rubella Avidity Control Set

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950158
Basic UDI-DI: 805432095ISID5330MC
Reference: IS-ID5330
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950134

IDS CMV Avidity Control Set

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950134
Basic UDI-DI: 805432095ISID5530MN
Reference: IS-ID5530
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950127

IDS CMV Control Set

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950127
Basic UDI-DI: 805432095ISID5430MH
Reference: IS-ID5430
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950110

IDS Rubella Control Set

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950110
Basic UDI-DI: 805432095ISID5230M7
Reference: IS-ID5230
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

08054320950097

IDS TOXO Control Set

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Technogenetics S.p.A
Manufacturer SRN: IT-MF-000025331
UDI-DI: 08054320950097
Basic UDI-DI: 805432095ISID5030LV
Reference: IS-ID5030
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 17.07.2026 05:43

Manufacturer products View details

ADVIA Centaur Rub M quality control material

IVDR_67_TTN_DUB-C_C_REAG_Rubella M Quality Control Material

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414201443
Basic UDI-DI: 0405686901867WJ
Reference: 10310286
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CMTBRIFZK0163Z

CMTBRIFZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CMTBRIFZK0163Z
Basic UDI-DI: B-697603130CMTBRIFZK0163Z
Reference: CMTBRIFZK01-AHG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CMTBMDRZK01639

CMTBMDRZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CMTBMDRZK01639
Basic UDI-DI: B-697603130CMTBMDRZK01639
Reference: CMTBMDRZK01-AHG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CGBSZK01ACKM6

CGBSZK01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CGBSZK01ACKM6
Basic UDI-DI: B-697603130CGBSZK01ACKM6
Reference: CGBSZK01A-AHG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130CDGVZK01YJ4Z

CDGVZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130CDGVZK01YJ4Z
Basic UDI-DI: B-697603130CDGVZK01YJ4Z
Reference: CDGVZK01-AHG4E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMTBZK01DJEZ

AMTBZK01-AHG2E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMTBZK01DJEZ
Basic UDI-DI: B-69509960AMTBZK01DJEZ
Reference: AMTBZK01-AHG2E
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Control Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771101196
Basic UDI-DI: B-08056771101196
Reference: 317021
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 22:31

Manufacturer products View details

LIAISON® Control Anti-HAV

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100168
Basic UDI-DI: 80567713101713S
Reference: 310171
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:07

Manufacturer products View details

MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls

Dengue virus NS1 Antigen (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145565329
Basic UDI-DI: 69471455401VV
Reference: 160201401MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

NatQal HBV

NatQal HCV - HIV - HBV - HEV

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

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369292054
Basic UDI-DI: 376036929DGV0019K
Reference: 190015
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details

NatQal B19-L

NatQal 2

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

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369291965
Basic UDI-DI: 376036929DGV0029M
Reference: 247901
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details