Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

21.09.2026 18:16

Sync status

Successful

Device

3152549

Actor

47651

Certificate

3295

Active filter:Manufacturer SRN:DK-MF-000014089

140 device results listed.

Page 1 / 7

BGI

50 tests/kit, 400 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468669
Basic UDI-DI
5745000468EU01001100508G
Reference
EU0100110050
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Denmark
Authorised representative
-
Last updated
04.08.2026 21:45
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
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
BGI

1 test/kit

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468140
Basic UDI-DI
B-05745000468140
Reference
MFG030029
EMDN
W0105040519
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Poland
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
IVD Annex II List BIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468119
Basic UDI-DI
B-05745000468119
Reference
MFG02001
EMDN
W02050192
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
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
BGI

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468058
Basic UDI-DI
B-05745000468058
Reference
MFG030015
EMDN
W0105040519
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
Denmark
Authorised representative
-
Last updated
02.08.2026 22:56
05745000468072

Oseq-gBRCA-1, Oseq-gBRCA-2

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468072
Basic UDI-DI
B-05745000468072
Reference
MFG020003
EMDN
W02050192
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
02.08.2026 22:56
05745000468065

Seq-hpv-1, Seq-hpv-2

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468065
Basic UDI-DI
B-05745000468065
Reference
MFG020002
EMDN
W0105041003
EMDN description
PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country
Denmark
Authorised representative
-
Last updated
02.08.2026 22:55
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
IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468027
Basic UDI-DI
B-05745000468027
Reference
MFG030021
EMDN
W0105041004
EMDN description
FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country
Denmark
Authorised representative
-
Last updated
02.08.2026 22:55
BGI

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468010
Basic UDI-DI
B-05745000468010
Reference
MFG030010
EMDN
W0105040519
EMDN description
CORONAVIRUS - NA REAGENTS
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