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Nucleic acid extraction and purification kit

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691103
Basic UDI-DI: 6974677691103HV
Reference: IS-TQ-009-96-2
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691097
Basic UDI-DI: 6974677691097JT
Reference: IS-TQ-009-96-1
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690458
Basic UDI-DI: 6974677690458JW
Reference: TQ-BG-007-96B-96
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690441
Basic UDI-DI: 6974677690441JD
Reference: TQ-BG-004-96D-96
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

96 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690427
Basic UDI-DI: 6974677690427JK
Reference: TQ-BG-003-96B-96
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic acid extraction and purification kit

50 tests/kit

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677690410
Basic UDI-DI: 6974677690410J2
Reference: TQ-BG-001-50
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:12

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931045
Basic UDI-DI: 697070393GAC00182
Reference: Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931038
Basic UDI-DI: 697070393BRC001BU
Reference: BRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Colorectal Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931021
Basic UDI-DI: 697070393CRC001C9
Reference: CRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）

30 tests per kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703931014
Basic UDI-DI: 697070393LUC001GX
Reference: Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 16.07.2026 10:58

Manufacturer products Authorised representative products Authorised representative actors View details

NIFTY®

96 tests

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510238
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030110, MFG030111, MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Denmark
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 16.07.2026 10:07

Manufacturer products Open in EUDAMED View details

ipsogen JAK2 RGQ PCR Kit

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

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228015444
Basic UDI-DI: 4053228RJAK2RGQ00000001RJ
Reference: 674623
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 08:31

Manufacturer products View details

PredicineCARE Assay

PredicineCARE DeepSEA 1.7.3

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Predicine, Inc.
Manufacturer SRN: US-MF-000031888
UDI-DI: 00860013997625
Basic UDI-DI: 08600139976PDCA9999KER6
Reference: PD-CA9999KE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

CytoScan Dx Array, 6 pk

CytoScan Dx Assay, a part of CytoScan™ Dx Test

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Affymetrix, Inc.
Manufacturer SRN: US-MF-000028847
UDI-DI: 00856826006098
Basic UDI-DI: 0856826006902420G9
Reference: 902150 (902420)
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

Oncotype DX Breast Recurrence Score® Computational Software

Oncotype DX Breast Recurrence Score® Test

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Genomic Health Inc.
Manufacturer SRN: US-MF-000018730
UDI-DI: 00852867008022
Basic UDI-DI: 0852867008100406DG
Reference: 302774
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

clonoSEQ Assay B-Cell Reagent Set

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Adaptive Biotechnologies Corporation
Manufacturer SRN: US-MF-000029850
UDI-DI: 00850023038005
Basic UDI-DI: 0850023038A040FN
Reference: A040
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: France
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

AmplideX Fragile X Dx & Carrier Screen Kit

IVD Class CIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: Asuragen, Inc.
Manufacturer SRN: US-MF-000011830
UDI-DI: 00850017493124
Basic UDI-DI: 0850017493A011248A
Reference: A01124
EMDN: W0106010104
EMDN description: FRAGILE X SYNDROME
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:15

Manufacturer products Authorised representative products Authorised representative actors View details

Twist Precision Exome Dx Panel, 2 reactions

Twist Precision Exome Dx Panel

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Twist Bioscience Corporation
Manufacturer SRN: US-MF-000039181
UDI-DI: 00810119550149
Basic UDI-DI: 081011955TPEDxPA7
Reference: 107619
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QAdvis EAR AB
Last updated: 16.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

Twist Precision Prep and Enrichment Dx Kit, 16 samples - Box 1

Twist Precision Prep and Enrichment Dx Kit

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Twist Bioscience Corporation
Manufacturer SRN: US-MF-000039181
UDI-DI: 00810119550071
Basic UDI-DI: 081011955TPPEDxKLE
Reference: 107621
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QAdvis EAR AB
Last updated: 16.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details

Twist Precision Exome Dx Kit, 96 samples (A) - Box 1

Twist Precision Exome Dx Kit

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Twist Bioscience Corporation
Manufacturer SRN: US-MF-000039181
UDI-DI: 00810119550002
Basic UDI-DI: 081011955TPEDxK9V
Reference: 104993
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: QAdvis EAR AB
Last updated: 16.07.2026 03:54

Manufacturer products Authorised representative products Authorised representative actors View details