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TREN

Last updated

21.09.2026 21:15

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Successful

Device

3261245

Actor

47660

Certificate

3311

Active filter:Manufacturer SRN:DK-MF-000014089

140 device results listed.

Page 3 / 7

CSVXML
BGI

32tests

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468188
Basic UDI-DI
5745000468MFG010035G4
Reference
MFG010035
EMDN
W0105900101
EMDN description
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:40
Manufacturer productsView details
BGI

48 tests

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468171
Basic UDI-DI
5745000468MFG010019G6
Reference
MFG010019
EMDN
W0105900101
EMDN description
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:40
Manufacturer productsView details
BGI

1 tube/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468164
Basic UDI-DI
5745000468HKM910001MS
Reference
HKM910001
EMDN
W050101010201
EMDN description
BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:40
Manufacturer productsView details
05745000468157

BGI SEQ-500

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentKitMicrobial substancesProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468157
Basic UDI-DI
5745000468BGISEQ-500PX
Reference
BGISEQ-500
EMDN
W02050192
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:40
Manufacturer productsView details
BGI

35cycles/run, 1run

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468102
Basic UDI-DI
5745000468MFG010010FL
Reference
MFG010010
EMDN
W010699
EMDN description
GENETIC TESTS - OTHER
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:40
Manufacturer productsView details
Nucleic Acid Extraction Kit

96 tests

IVD Class AIVDR 2017/746On the marketKitReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05745000468089
Basic UDI-DI
5745000468MFG010011FN
Reference
MFG010011
EMDN
W0105900102
EMDN description
REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:40
Manufacturer productsView details
05744003510146

BGI LMSQ-1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05744003510146
Basic UDI-DI
574400351EU0200080001RZ
Reference
EU0200080001
EMDN
W0201050299
EMDN description
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - OTHER
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:38
Manufacturer productsView details
05744003510139

BGI LMSP-192

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
05744003510139
Basic UDI-DI
574400351EU0200070001RN
Reference
EU0200070001
EMDN
W02069099
EMDN description
VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country
Denmark
Authorised representative
-
Last updated
31.07.2026 12:38
Manufacturer productsView 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 productsOpen in EUDAMEDView details
BGI

knowliter-1

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-knowliter-1KS
Basic UDI-DI
B-knowliter-1KS
Reference
knowliter-1
EMDN
W02050182
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 14:20
Manufacturer productsView details
BGI

Sentis-PanCancer

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-Sentis-PanCancer99
Basic UDI-DI
B-Sentis-PanCancer99
Reference
Sentis-PanCancer
EMDN
Z129092
EMDN description
VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 10:48
Manufacturer productsView details
BGI

Sentis-PanCancer-CL

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-Sentis-PanCancer-CLAD
Basic UDI-DI
B-Sentis-PanCancer-CLAD
Reference
Sentis-PanCancer-CL
EMDN
Z129092
EMDN description
VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 10:48
Manufacturer productsView details
BGI

Sentis-LungCT

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-Sentis-LungCTKY
Basic UDI-DI
B-Sentis-LungCTKY
Reference
Sentis-LungCT
EMDN
Z129092
EMDN description
VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 10:48
Manufacturer productsView details
BGI

Sentis-LungCT-CL

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-Sentis-LungCT-CL5D
Basic UDI-DI
B-Sentis-LungCT-CL5D
Reference
Sentis-LungCT-CL
EMDN
Z129092
EMDN description
VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 10:48
Manufacturer productsView details
BGI

SIGVAR

IVD generalIVDDOn the marketProfessional testing
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-SIGVARNZ
Basic UDI-DI
B-SIGVARNZ
Reference
SIGVAR
EMDN
W02050182
EMDN description
NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 06:29
Manufacturer productsView details
BGI

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-SAI2022020HN
Basic UDI-DI
B-SAI2022020HN
Reference
SAI2022020
EMDN
W0101060107
EMDN description
HBA1C TEST STRIPS
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 05:36
Manufacturer productsView details
BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-SAI2022019J5
Basic UDI-DI
B-SAI2022019J5
Reference
SAI2022019
EMDN
W0101060107
EMDN description
HBA1C TEST STRIPS
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 05:36
Manufacturer productsView details
BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-SAI2022018J3
Basic UDI-DI
B-SAI2022018J3
Reference
SAI2022018
EMDN
W0101060107
EMDN description
HBA1C TEST STRIPS
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 05:36
Manufacturer productsView details
BGI

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-SAI2022016HX
Basic UDI-DI
B-SAI2022016HX
Reference
SAI2022016
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 05:36
Manufacturer productsView details
BGI

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
BGI EUROPE A/S
Manufacturer SRN
DK-MF-000014089
UDI-DI
D-SAI2022015HV
Basic UDI-DI
B-SAI2022015HV
Reference
SAI2022015
EMDN
W0102060309
EMDN description
25-HYDROXYVITAMIN D
First on market country
Denmark
Authorised representative
-
Last updated
15.07.2026 05:36
Manufacturer productsView details