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

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17.07.2026 02:49

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Active filter:Manufacturer SRN:DK-MF-000014089

140 device results listed.

Page 4 / 7

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022002E2
Basic UDI-DI: B-SAC2022002E2
Reference: SAC2022002
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022001DY
Basic UDI-DI: B-SAC2022001DY
Reference: SAC2022001
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030065R2
Basic UDI-DI: B-MFG030065R2
Reference: MFG030065
EMDN: W01021399
EMDN description: CARDIAC MARKERS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

96 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030064QY
Basic UDI-DI: B-MFG030064QY
Reference: MFG030064
EMDN: W01010224
EMDN description: PHOSPHOLIPIDS
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030063QW
Basic UDI-DI: B-MFG030063QW
Reference: MFG030063
EMDN: W0102050212
EMDN description: SOLUBLE FMS-LIKE TYROSINE KINASE-1
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

48 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030062QU
Basic UDI-DI: B-MFG030062QU
Reference: MFG030062
EMDN: W0102080399
EMDN description: ANTIBIOTICS TDM - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

96 tests/kit-B

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030059R7
Basic UDI-DI: B-MFG030059R7
Reference: MFG030059
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

96 tests/kit-A

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-MFG030058R5
Basic UDI-DI: B-MFG030058R5
Reference: MFG030058
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 14.07.2026 05:06

Manufacturer products View details

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-EU0100030050EN
Basic UDI-DI: B-EU0100030050EN
Reference: EU0100030050
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: 13.07.2026 21:08

Manufacturer products View details

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-EU0100020050EB
Basic UDI-DI: B-EU0100020050EB
Reference: EU0100020050
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 13.07.2026 21:08

Manufacturer products View details

50 tests/package

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-EU0100010050DY
Basic UDI-DI: B-EU0100010050DY
Reference: EU0100010050
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 13.07.2026 21:08

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510313
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 22:44

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510245
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030110
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510252
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030110
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510269
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030111
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510276
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030111
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510283
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030111
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510290
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

-

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510306
Basic UDI-DI: 574400351MFG03011085
Reference: MFG030112
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: -
Safety summary (SSCP/SSP): BGIEU-STP-CE-116-011 · Rev. 3
Authorised representative: -
Last updated: 02.07.2026 06:32

Manufacturer products Open in EUDAMED View details

48 tests/kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468683
Basic UDI-DI: 5745000468EU0100170048AX
Reference: EU0100170048
EMDN: -
EMDN description: GENETIC TESTS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 05:05

Manufacturer products View details