- Manufacturer
- Ingenetix GmbH
- Manufacturer SRN
- AT-MF-000001501
- UDI-DI
- 09120110506405
- Basic UDI-DI
- 912011050HUFGRXX8D
- Reference
- HUFG500
- EMDN
- W0106010499
- EMDN description
- POLYMORPHISM TESTS - OTHER
- First on market country
- -
- Safety summary (SSCP/SSP)
- FB257_V04 · Rev. 3.0
- Authorised representative
- -
- Last updated
- 11.07.2026 15:57
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
03.08.2026 14:01
Sync status
Successful
Device
2994098
Actor
47526
Certificate
3174
AlloSeq HCT
- Manufacturer
- CareDx Pty Ltd
- Manufacturer SRN
- AU-MF-000046711
- UDI-DI
- 19358706000106
- Basic UDI-DI
- B-19358706000106
- Reference
- ASHCT.1(96)-IVD
- EMDN
- W0106010499
- EMDN description
- POLYMORPHISM TESTS - OTHER
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 11.07.2026 14:12
AlloSeq cfDNA
- Manufacturer
- CareDx Pty Ltd
- Manufacturer SRN
- AU-MF-000046711
- UDI-DI
- 19358706000083
- Basic UDI-DI
- B-19358706000083
- Reference
- ASCF.1(24)-IVD
- EMDN
- W0106010499
- EMDN description
- POLYMORPHISM TESTS - OTHER
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 11.07.2026 14:12
High Myopia Risk Prediction Gene Test Kit (Gene sequencing)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690088
- Basic UDI-DI
- B-16975843690088
- Reference
- 480 tests/kit
- EMDN
- W0106010499
- EMDN description
- POLYMORPHISM TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
High Myopia Risk Prediction Gene Test Kit (Gene sequencing)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690071
- Basic UDI-DI
- B-16975843690071
- Reference
- 96 tests/kit
- EMDN
- W0106010499
- EMDN description
- POLYMORPHISM TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690064
- Basic UDI-DI
- B-16975843690064
- Reference
- 48 tests/kit
- EMDN
- W0106010299
- EMDN description
- POLYGENETIC DISORDERS TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690057
- Basic UDI-DI
- B-16975843690057
- Reference
- 24 tests/kit
- EMDN
- W0106010299
- EMDN description
- POLYGENETIC DISORDERS TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
Leber Hereditary Optic Neuropathy Mitochondria Gene Testing Kit (Fluorescence PCR)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690040
- Basic UDI-DI
- B-16975843690040
- Reference
- 12 tests/kit
- EMDN
- W0106010299
- EMDN description
- POLYGENETIC DISORDERS TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690033
- Basic UDI-DI
- B-16975843690033
- Reference
- 48 tests/kit
- EMDN
- W0106010299
- EMDN description
- POLYGENETIC DISORDERS TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
Corneal Dystrophy TGFBI Gene Testing Kit (Fluorescence PCR)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690026
- Basic UDI-DI
- B-16975843690026
- Reference
- 24 tests/kit
- EMDN
- W0106010299
- EMDN description
- POLYGENETIC DISORDERS TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
Corneal Dystrophy TGFBI Gene Testing Kit(Fluorescence PCR)
- Manufacturer
- PSI Gene Technology Co.,Ltd.
- Manufacturer SRN
- CN-MF-000023276
- UDI-DI
- 16975843690019
- Basic UDI-DI
- B-16975843690019
- Reference
- 12 tests/kit
- EMDN
- W0106010299
- EMDN description
- POLYGENETIC DISORDERS TESTS - OTHER
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 10:09
FMR1 CGG PCR
- Manufacturer
- Beijing Healthgene Laboratory Co.,Ltd
- Manufacturer SRN
- CN-MF-000032465
- UDI-DI
- D-10106010104029X2
- Basic UDI-DI
- B-10106010104029X2
- Reference
- 100 Tests/Kit
- EMDN
- W0106010104
- EMDN description
- FRAGILE X SYNDROME
- First on market country
- Netherlands
- Authorised representative
- Lotus NL B.V.
- Last updated
- 11.07.2026 00:37
Synthetic Positive Controls for Haemochromatosis
- Manufacturer
- AusDiagnostics Pty Ltd
- Manufacturer SRN
- AU-MF-000020558
- UDI-DI
- 09343044003547
- Basic UDI-DI
- B-09343044003547
- Reference
- 91171
- EMDN
- W0106010105
- EMDN description
- HAEMOCHROMATOSIS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 10.07.2026 23:43
Step 1 Tubes for Haemochromatosis 8-well
- Manufacturer
- AusDiagnostics Pty Ltd
- Manufacturer SRN
- AU-MF-000020558
- UDI-DI
- 09343044002335
- Basic UDI-DI
- B-09343044002335
- Reference
- 23156S
- EMDN
- W0106010105
- EMDN description
- HAEMOCHROMATOSIS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 10.07.2026 23:42
Step 2 Plates for Haemochromatosis 8-well
- Manufacturer
- AusDiagnostics Pty Ltd
- Manufacturer SRN
- AU-MF-000020558
- UDI-DI
- 09343044002328
- Basic UDI-DI
- B-09343044002328
- Reference
- 23156P
- EMDN
- W0106010105
- EMDN description
- HAEMOCHROMATOSIS
- First on market country
- Malta
- Authorised representative
- Advena Limited
- Last updated
- 10.07.2026 23:42
601380025
- Manufacturer
- Molbio Diagnostics Limited
- Manufacturer SRN
- IN-MF-000028386
- UDI-DI
- 08908020139507
- Basic UDI-DI
- B-08908020139507
- Reference
- 601380025
- EMDN
- W0106010401
- EMDN description
- HLA-TYPING
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 10.07.2026 21:30
601380050
- Manufacturer
- Molbio Diagnostics Limited
- Manufacturer SRN
- IN-MF-000028386
- UDI-DI
- 08908007989842
- Basic UDI-DI
- B-08908007989842
- Reference
- 601380050
- EMDN
- W0106010401
- EMDN description
- HLA-TYPING
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 10.07.2026 21:27
601380020
- Manufacturer
- Molbio Diagnostics Limited
- Manufacturer SRN
- IN-MF-000028386
- UDI-DI
- 08908007989835
- Basic UDI-DI
- B-08908007989835
- Reference
- 601380020
- EMDN
- W0106010401
- EMDN description
- HLA-TYPING
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 10.07.2026 21:27
601380005
- Manufacturer
- Molbio Diagnostics Limited
- Manufacturer SRN
- IN-MF-000028386
- UDI-DI
- 08908007989828
- Basic UDI-DI
- B-08908007989828
- Reference
- 601380005, 601380020, 601380025, 601380050
- EMDN
- W0106010401
- EMDN description
- HLA-TYPING
- First on market country
- Belgium
- Authorised representative
- QbD RepS BV
- Last updated
- 10.07.2026 21:27
Anyplex™ II Thrombosis SNP Panel Assay
- Manufacturer
- Seegene, Inc.
- Manufacturer SRN
- KR-MF-000022275
- UDI-DI
- 08809240103906
- Basic UDI-DI
- B-08809240103906
- Reference
- TS10390Z
- EMDN
- W0106010199
- EMDN description
- MONOGENETIC DISORDERS TESTS - OTHER
- First on market country
- Germany
- Authorised representative
- Medical Technology Promedt Consulting GmbH
- Last updated
- 10.07.2026 12:46