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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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171 device results listed.

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Quality Control (CEA)

M3801Q, M3802Q

IVD generalIVDDOn the marketNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760067
Basic UDI-DI: B-06979469760067
Reference: M3801Q
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:39

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control (CEA)

M3802Q

IVD generalIVDDOn the marketNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760074
Basic UDI-DI: B-06979469760074
Reference: M3802Q
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:39

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Control

C1: 1*1 mL C2: 1*1 mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896415366
Basic UDI-DI: B-06978896415366
Reference: W-C-AFP-1
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Control

C1: 1*1 mL C2: 1*1 mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
Manufacturer SRN: CN-MF-000019908
UDI-DI: 06978896415359
Basic UDI-DI: B-06978896415359
Reference: W-C-CEA-1
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors View details

06974873630333

Positive Control(Lyophilized preparation x1 bottle, redissolved volume 1 mL); Negative Control(Lyophilized preparation x1 bottle, redissovled volume 1mL)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Code Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000048158
UDI-DI: 06974873630333
Basic UDI-DI: B-06974873630333
Reference: KD7003-C
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:01

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06974873630104

L1:Level 1(lyophilized powder x1 bottle, redissolved volume 1.2 mL);L2: Level 2(lyophilized powder x1 bottle, redissolved volume 1.2 mL)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Code Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000048158
UDI-DI: 06974873630104
Basic UDI-DI: B-06974873630104
Reference: KD7001-C
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 21:01

Manufacturer products Authorised representative products Authorised representative actors View details

β2-MG Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003403
Basic UDI-DI: B-06974521003403
Reference: QC704
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003205
Basic UDI-DI: B-06974521003205
Reference: QC503
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:34

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003199
Basic UDI-DI: B-06974521003199
Reference: QC502
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:34

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CLIA CEA Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001171
Basic UDI-DI: B-06974521001171
Reference: MQC026
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

CLIA AFP Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001140
Basic UDI-DI: B-06974521001140
Reference: MQC025
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:29

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Multi Control

IVD Class CNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904096902
Basic UDI-DI: 69449040004L-TM-Con****UY
Reference: 105-007374-00
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

00884883003804

TUM-S1

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883003804
Basic UDI-DI: B-00884883003804
Reference: TUM-S1
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:18

Manufacturer products Authorised representative products Authorised representative actors View details

00884883002463

TUM-303

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883002463
Basic UDI-DI: B-00884883002463
Reference: TUM-303
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

00884883002456

TUM-202

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883002456
Basic UDI-DI: B-00884883002456
Reference: TUM-202
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

00884883002449

TUM-101

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Microgenics Corporation
Manufacturer SRN: US-MF-000030375
UDI-DI: 00884883002449
Basic UDI-DI: B-00884883002449
Reference: TUM-101
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® TUMOR MARKERS Test Set

407sa

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005739
Basic UDI-DI: B-00859110005739
Reference: 407sa
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® TUMOR MARKERS Test Set

407re

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00859110005722
Basic UDI-DI: B-00859110005722
Reference: 407re
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

VALIDATE® TUMOR MARKERS Test Set

407ab

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000029697
UDI-DI: 00850011135266
Basic UDI-DI: B-00850011135266
Reference: 407ab
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech Free PSA Control

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048511
Basic UDI-DI: 880613306142D2
Reference: CFPO-406
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details