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174 device results listed.

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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

MAGLUMI PAP (CLIA) Controls

PAP (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: 06947145529161
Basic UDI-DI: 69471455456WN
Reference: 160201456MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI β2-Microglobulin (CLIA) Controls

β2-Microglobulin (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: 06947145520984
Basic UDI-DI: 69471455489X5
Reference: 160201489MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI CA 242 (CLIA) Controls

CA 242 (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515522
Basic UDI-DI: 69471455226W3
Reference: 160201226MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI CA 50 (CLIA) Controls

CA 50 (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515492
Basic UDI-DI: 69471455223VV
Reference: 160201223MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HER-2 (CLIA) Controls

HER-2 (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515348
Basic UDI-DI: 69471455422W5
Reference: 160201422MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI ProGRP (CLIA) Controls

ProGRP (CLIA) Controls

IVD Class CIVDR 2017/746On the marketMicrobial substancesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145515157
Basic UDI-DI: 69471455420VZ
Reference: 160201420MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:51

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI TPA (CLIA) Controls

TPA (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145523329
Basic UDI-DI: 694714551012HK
Reference: 1602011012MT
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Multi Control

105-007385-00,105-007381-00, 105-007373-00,105-007377-00, 105-007386-00,105-007382-00, 105-007374-00, 105-007378-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908867
Basic UDI-DI: 69449040004L-TM-Con****UY
Reference: 105-007381-00
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Multi Control II

105-010146-00, 105-010156-00 105-010151-00, 105-010161-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908218
Basic UDI-DI: 69449040004V-TMII-Con**DV
Reference: 105-010146-00
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Control H

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164458
Basic UDI-DI: 49874814987481164390UP
Reference: 993-61101
EMDN: W0102152005
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako DCP Control H

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164496
Basic UDI-DI: 49874814987481164413UA
Reference: 991-61401
EMDN: W0102152005
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 01.07.2026 10:36

Manufacturer products Authorised representative products Authorised representative actors View details

Boditech iFOB Neo Control

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133048962
Basic UDI-DI: 880613306006CR
Reference: CFPO-14
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 01.07.2026 05:38

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050867
Basic UDI-DI: 697492505000005TC
Reference: BYZKH0303
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050829
Basic UDI-DI: 697492505000005TC
Reference: BYZKH0203
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050782
Basic UDI-DI: 697492505000005TC
Reference: BYZKH0103
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Tumor Marker Control

Analyzer (automatic and non-automatic)

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

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050768
Basic UDI-DI: 697492505000005TC
Reference: BYZKH0101
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

NSE Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815405
Basic UDI-DI: 697388081074PD
Reference: ZCC122
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details