- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
- Manufacturer SRN
- TW-MF-000023414
- UDI-DI
- 04719878570602
- Basic UDI-DI
- B-04719878570602
- Reference
- PCRAD1115
- EMDN
- W0106010199
- EMDN description
- MONOGENETIC DISORDERS TESTS - OTHER
- First on market country
- Spain
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 03.08.2026 09:40
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
24.09.2026 18:39
Sync status
Successful
Device
3610667
Actor
47885
Certificate
3409
IVD generalNot specifiedOn the marketSingle use
IVD Annex II List BIVDDOn the marketKitProfessional testingReagentSingle use
- Manufacturer
- Omixon Biocomputing Ltd.
- Manufacturer SRN
- HU-MF-000003018
- UDI-DI
- 05999565780678
- Basic UDI-DI
- B-05999565780678
- Reference
- H32.1
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- France
- Authorised representative
- -
- Last updated
- 03.08.2026 03:24
05745000468874
96 tests/kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468874
- Basic UDI-DI
- B-05745000468874
- Reference
- MFG030049
- EMDN
- W0106010399
- EMDN description
- CHROMOSOMAL DISORDERS TESTS - OTHER
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468836
- Basic UDI-DI
- B-05745000468836
- Reference
- MFG030014
- EMDN
- W01060299
- EMDN description
- TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468782
1152T
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468782
- Basic UDI-DI
- B-05745000468782
- Reference
- MFG030032
- EMDN
- W0106010111
- EMDN description
- THALASSAEMIA
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468508
Sentis-PanCancer, Sentis-PanCancer-CL
IVD generalIVDDOn the marketProfessional testing
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468508
- Basic UDI-DI
- B-05745000468508
- Reference
- MFG020007
- EMDN
- W01060202
- EMDN description
- K-RAS
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468492
- Basic UDI-DI
- B-05745000468492
- Reference
- MFG030041
- EMDN
- W01060202
- EMDN description
- K-RAS
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468386
50 tests/kit, 200 tests/kit
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468386
- Basic UDI-DI
- B-05745000468386
- Reference
- MFG030034, MFG030035
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468133
Detection Kit for Noninvasive Fetal Trisomy(T21, T18, T13)Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)
IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468133
- Basic UDI-DI
- B-05745000468133
- Reference
- MFG030009
- EMDN
- W0106010304
- EMDN description
- PÄTAU SYNDROME
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468126
Detection Kit for Noninvasive Fetal Trisomy(T21, T18, T13)Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)
IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468126
- Basic UDI-DI
- B-05745000468126
- Reference
- MFG030008
- EMDN
- W0106010304
- EMDN description
- PÄTAU SYNDROME
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468096
Detection Kit for Noninvasive Fetal Trisomy(T21, T18, T13)Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)
IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468096
- Basic UDI-DI
- B-05745000468096
- Reference
- MFG030007
- EMDN
- W0106010301
- EMDN description
- DOWN'S SYNDROME
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:56
05745000468034
32 tests/kit, 64tests/kit
IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05745000468034
- Basic UDI-DI
- B-05745000468034
- Reference
- MFG030013, MFG030019
- EMDN
- W01060203
- EMDN description
- BRCA 1+2
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:55
05744003510382
PMseq-PM-1
IVD generalIVDDOn the marketProfessional testing
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510382
- Basic UDI-DI
- B-05744003510382
- Reference
- MFG020007
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:55
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510375
- Basic UDI-DI
- B-05744003510375
- Reference
- MFG030057
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:55
05744003510344
48 tests/kit
IVD generalIVDDOn the marketKitReagent
- Manufacturer
- BGI EUROPE A/S
- Manufacturer SRN
- DK-MF-000014089
- UDI-DI
- 05744003510344
- Basic UDI-DI
- B-05744003510344
- Reference
- MFG030051
- EMDN
- W010699
- EMDN description
- GENETIC TESTS - OTHER
- First on market country
- Denmark
- Authorised representative
- -
- Last updated
- 02.08.2026 22:55
OD002
OD002
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- OncoDNA
- Manufacturer SRN
- BE-MF-000021570
- UDI-DI
- 05430003021576
- Basic UDI-DI
- B-05430003021576
- Reference
- OD002
- EMDN
- W01060299
- EMDN description
- TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
- First on market country
- Belgium
- Authorised representative
- -
- Last updated
- 02.08.2026 21:51
LAMP Human Lactose Intolerance Duplex KIT
LC-LacIDuplex-LP-24
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- LaCAR MDx Technologies
- Manufacturer SRN
- BE-MF-000001212
- UDI-DI
- 05430002471532
- Basic UDI-DI
- B-05430002471532
- Reference
- LC-LacIDuplex-LP-24
- EMDN
- W0106010199
- EMDN description
- MONOGENETIC DISORDERS TESTS - OTHER
- First on market country
- Belgium
- Authorised representative
- -
- Last updated
- 02.08.2026 21:50
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- LaCAR MDx Technologies
- Manufacturer SRN
- BE-MF-000001212
- UDI-DI
- 05430002471525
- Basic UDI-DI
- B-05430002471525
- Reference
- LC-HbS/C-LP
- EMDN
- W0106010109
- EMDN description
- SICKLE CELL ANEMIA
- First on market country
- Belgium
- Authorised representative
- -
- Last updated
- 02.08.2026 21:50
LAMP Human PAI-1 mutation KIT
LC-PAI1-LP
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- LaCAR MDx Technologies
- Manufacturer SRN
- BE-MF-000001212
- UDI-DI
- 05430002471419
- Basic UDI-DI
- B-05430002471419
- Reference
- LC-PAI1-LP-24
- EMDN
- W0106010199
- EMDN description
- MONOGENETIC DISORDERS TESTS - OTHER
- First on market country
- Belgium
- Authorised representative
- -
- Last updated
- 02.08.2026 21:50
LAMP Human HLA Coeliac direct KIT
LC-HLACD-LP-96
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- LaCAR MDx Technologies
- Manufacturer SRN
- BE-MF-000001212
- UDI-DI
- 05430002471273
- Basic UDI-DI
- B-05430002471273
- Reference
- LC-HLACD-LP-96
- EMDN
- W0106010499
- EMDN description
- POLYMORPHISM TESTS - OTHER
- First on market country
- Belgium
- Authorised representative
- -
- Last updated
- 02.08.2026 21:50