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EUDAMED Device Search

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

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03.08.2026 06:01

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704 device results listed.

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Toxo IgG Avidity Control

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053059992
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029876-00
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG Avidity Control

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060004
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029878-00
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG Avidity Control

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060011
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029879-00
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii IgG Avidity（CLIA）

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060035
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029867-00
EMDN: W0105080805
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG Avidity Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060066
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029872-00
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG Avidity Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060103
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029875-00
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxoplasma gondii IgG Avidity(CLIA)

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060127
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029863-00
EMDN: W0105080805
EMDN description: TOXOPLASMA ANTIBODY IGG - AVIDITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Toxo IgG Avidity Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053060134
Basic UDI-DI: 69449040AB74000255L
Reference: 105-029877-00
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM and HEV IgM Multi Control

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053070485
Basic UDI-DI: 69449040AB74000435N
Reference: 105-043941-00
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM and HEV IgM Multi Control

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053070522
Basic UDI-DI: 69449040AB74000435N
Reference: 105-043944-00
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM and HEV IgM Multi Control

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IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053070539
Basic UDI-DI: 69449040AB74000435N
Reference: 105-043942-00
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

IM4291315

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617419747
Basic UDI-DI: 69506174IM429315ER
Reference: IM4291315
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

SeroQal ALINI 6

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IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369291200
Basic UDI-DI: 376036929SMI001EV
Reference: 270428
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: -
Last updated: 27.06.2026 06:00

Manufacturer products View details

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IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300186
Basic UDI-DI: B-06937287300186
Reference: 2×1 mL (2 levels)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Rub G QC

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IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600536
Basic UDI-DI: 0405686902037V8
Reference: 10995671
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.06.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HCV Screening, 10x 1,2 mL

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IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956111
Basic UDI-DI: 0816784020096YG
Reference: NT01022
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HIV Screening, 10x 1,2 mL

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IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956173
Basic UDI-DI: 0816784020095YE
Reference: NT01032
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT HIV-2, 10x 1,2 mL

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IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956210
Basic UDI-DI: 0816784020102XJ
Reference: NT01036
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT NEG, 10x 1,2 mL

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IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956272
Basic UDI-DI: 0816784020093YA
Reference: NT01052
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

Optitrol NAT Triplex, 5x 1,2 mL

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IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850075956326
Basic UDI-DI: 0816784020092Y8
Reference: NT01041
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 22.06.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details