- 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
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
23.09.2026 12:14
Sync status
Successful
Device
3541632
Actor
47811
Certificate
3399
IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use
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
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
ipsogen JAK2 RGQ PCR Kit
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
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
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
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
clonoSEQ Assay B-Cell Reagent Set
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
AmplideX Fragile X Dx & Carrier Screen Kit
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
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
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
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
IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen MGI Biological Electronic Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000044825
- UDI-DI
- 06975996270369
- Basic UDI-DI
- 697599627S-Kit35
- Reference
- 940-002764-00
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- -
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 15.07.2026 23:02
IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen MGI Biological Electronic Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000044825
- UDI-DI
- 06975996270451
- Basic UDI-DI
- 697599627S-Kit35
- Reference
- 940-003025-00
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- -
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 15.07.2026 23:02
IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen MGI Biological Electronic Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000044825
- UDI-DI
- 06975996270437
- Basic UDI-DI
- 697599627S-Kit35
- Reference
- 940-003025-00
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- -
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 15.07.2026 23:02
IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen MGI Biological Electronic Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000044825
- UDI-DI
- 06975996270468
- Basic UDI-DI
- 697599627S-Kit35
- Reference
- 940-003026-00
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- -
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 15.07.2026 23:02
IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use
- Manufacturer
- Shenzhen MGI Biological Electronic Technology Co., Ltd.
- Manufacturer SRN
- CN-MF-000044825
- UDI-DI
- 06975996270444
- Basic UDI-DI
- 697599627S-Kit35
- Reference
- 940-003026-00
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- -
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 15.07.2026 23:02
Oncomine™ Dx Target Test (DNA and RNA Panel)
Oncomine™ Dx Target Test
IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitProfessional testingReagent
- Manufacturer
- Life Technologies Corporation
- Manufacturer SRN
- US-MF-000023929
- UDI-DI
- 10190302019620
- Basic UDI-DI
- 0190302A49756TV
- Reference
- A65534 (A65538)
- EMDN
- W01060299
- EMDN description
- TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Life Technologies Europe B.V.
- Last updated
- 15.07.2026 22:51
Genexus™ Dx Purification Supplies 2
Genexus™ Dx Purification Supplies 2, a part of Ion Torrent™ Genexus™ Dx FFPE DNA/RNA Purification Kit
IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent
- Manufacturer
- Life Technologies Corporation
- Manufacturer SRN
- US-MF-000023929
- UDI-DI
- 10190302017640
- Basic UDI-DI
- 0190302A51081RC
- Reference
- A51081 (A52170)
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Life Technologies Europe B.V.
- Last updated
- 15.07.2026 22:50
Genexus™ Dx Purification Supplies 1
Genexus™ Dx Purification Supplies 1, a part of Ion Torrent™ Genexus™ Dx cfTNA Purification Kit
IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent
- Manufacturer
- Life Technologies Corporation
- Manufacturer SRN
- US-MF-000023929
- UDI-DI
- 10190302017633
- Basic UDI-DI
- 0190302A51080RA
- Reference
- A51080 (A52171)
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Life Technologies Europe B.V.
- Last updated
- 15.07.2026 22:50