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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

31.07.2026 19:58

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Rotavirus and Adenovirus Combo Rapid Test

Rotavirus and Adenovirus Combo Rapid Test

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104432
Basic UDI-DI: 6970277510000DXH
Reference: IRAC-N625
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

B19 IgM CLIA Microparticles

AutoLumo analyzer

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552493
Basic UDI-DI: 697015090000276HT
Reference: CMK1203
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

B19 IgG CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552394
Basic UDI-DI: 697015090000275HR
Reference: CMK1103
EMDN: W0105040609
EMDN description: PARVOVIRUS B 19
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgM CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552349
Basic UDI-DI: 697015090000103GT
Reference: CMK0503
EMDN: W0105040310
EMDN description: HSV 2 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552295
Basic UDI-DI: 697015090000108H5
Reference: CMK1003
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgM CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552240
Basic UDI-DI: 697015090000102GR
Reference: CMK0403
EMDN: W0105040307
EMDN description: HSV 1 IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1 IgG CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552196
Basic UDI-DI: 697015090000107H3
Reference: CMK0903
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

CMV IgM CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552141
Basic UDI-DI: 697015090000100GM
Reference: CMK0203
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

CMV IgG CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359552097
Basic UDI-DI: 697015090000105GX
Reference: CMK0703
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella IgM CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359551946
Basic UDI-DI: 697015090000101GP
Reference: CMK0303
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella IgG CLIA Microparticles

Autolumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359551892
Basic UDI-DI: 697015090000106GZ
Reference: CMK0803
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus-1 IgG（CLIA）

105-012500-00、105-012501-00、105-012503-00、105-012504-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039574
Basic UDI-DI: 69449040AB740001159
Reference: 105-012503-00
EMDN: W0105040306
EMDN description: HSV 1 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus 1+2 IgG（CLIA）

105-012494-00、105-012495-00、105-012497-00、105-012498-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039550
Basic UDI-DI: 69449040AB74000135D
Reference: 105-012498-00
EMDN: W0105040303
EMDN description: HSV 1+2 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus-2 IgG（CLIA）

105-012506-00 、105-012507-00、105-012509-00、105-012510-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039529
Basic UDI-DI: 69449040AB74000125B
Reference: 105-012509-00
EMDN: W0105040309
EMDN description: HSV 2 IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Herpes Simplex Virus 1+2 IgM（CLIA）

105-012488-00、105-012489-00、105-012491-00、105-012492-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039512
Basic UDI-DI: 69449040AB74000145F
Reference: 105-012489-00
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

Cytomegalovirus IgG (CLIA)

105-012536-00, 105-012537-00, 105-012539-00, 105-012540-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021234
Basic UDI-DI: 69449040004W-CMVIgG****6D
Reference: 105-012540-00
EMDN: W0105040203
EMDN description: CMV IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Cytomegalovirus IgM (CLIA)

105-012542-00, 105-012543-00, 105-012545-00, 105-012546-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021067
Basic UDI-DI: 69449040004W-CMVIgM****8F
Reference: 105-012543-00
EMDN: W0105040204
EMDN description: CMV IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella Virus IgM (CLIA)

105-012512-00, 105-012513-00, 105-012515-00, 105-012516-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053021043
Basic UDI-DI: 69449040004W-RVIgM*****DU
Reference: 105-012513-00
EMDN: W0105040103
EMDN description: RUBELLA VIRUS IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Rubella Virus IgG (CLIA)

105-012518-00, 105-012519-00, 105-012521-00, 105-012522-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053020909
Basic UDI-DI: 69449040004W-RVIgG*****BE
Reference: 105-012522-00
EMDN: W0105040102
EMDN description: RUBELLA VIRUS IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

Virus RNA Collection Kit

-

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212446
Basic UDI-DI: B-06933260212446
Reference: /
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details