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TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930511
Basic UDI-DI: 89080153043B1321KV
Reference: 3B1321/C
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930481
Basic UDI-DI: 89080153043B1301KP
Reference: 3B1301/C
EMDN: W0106010103
EMDN description: FACTOR V LEIDEN
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® HLA B-27 Real-Time PCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930450
Basic UDI-DI: 89080153043B247NM
Reference: 3B247/C
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:03

Manufacturer products Authorised representative products Authorised representative actors View details

MULTIGEN

HEMOPHILIA B Yeni Nesil Dizi Analizi ile F9 Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090349EL
Basic UDI-DI: 8681957090349EL
Reference: M-F9-01
EMDN: W0106010117
EMDN description: OTHER HEMOPHILIA MUTATIONS (VWF, F8, F9)
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:40

Manufacturer products View details

8681957090072DY

FAST-HBB NGS Sequencing Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090072DY
Basic UDI-DI: 8681957090072DY
Reference: M-HBB-01
EMDN: W0106010111
EMDN description: THALASSAEMIA
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

MULTİGEN

Yeni Nesil Dizi Analizi ile CFTR Mutasyonlarını Saptama Kiti

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090041DM
Basic UDI-DI: 8681957090041DM
Reference: M-CF-01
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Türkiye
Authorised representative: -
Last updated: 03.07.2026 17:39

Manufacturer products View details

gb GENETIC HFE

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: GENERI BIOTECH s.r.o.
Manufacturer SRN: CZ-MF-000018857
UDI-DI: 08595223920812
Basic UDI-DI: 85952239000005X4
Reference: 3208-025
EMDN: W0106010105
EMDN description: HAEMOCHROMATOSIS
First on market country: Czechia
Authorised representative: -
Last updated: 03.07.2026 16:57

Manufacturer products View details

37350134361787

SPOT-it TREC & SMN1 Screening Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ImmunoIVD AB
Manufacturer SRN: SE-MF-000034517
UDI-DI: 37350134361787
Basic UDI-DI: 7350134361789C
Reference: 4-2020-TS
EMDN: W0106010199
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:12

Manufacturer products View details

DEV-5 Dye Set, MultiCap

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Devyser AB
Manufacturer SRN: SE-MF-000001699
UDI-DI: 07350040632062
Basic UDI-DI: 7350040638R401RJ
Reference: 8-R401
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:51

Manufacturer products View details

NIFTY®

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

06974776970000

160 tests/kit

IVD Class AIVDR 2017/746On the marketKit

Manufacturer: CapitalBio Genomics Co.,Ltd.
Manufacturer SRN: CN-MF-000027716
UDI-DI: 06974776970000
Basic UDI-DI: 697477697FAL01RS
Reference: 160 tests/kit
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

Vanadis Core Reagent Cartridge II

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147382507
Basic UDI-DI: 6438147Vanadis_RC2XU
Reference: 3222-002B
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

Eonis SCID-SMA kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147377725
Basic UDI-DI: 6438147Eonis_SCID-SMA62
Reference: 3241-0010
EMDN: W0106010299
EMDN description: POLYGENETIC DISORDERS TESTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

NIFTY®

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

NIFTY®

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

NIFTY®

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

NIFTY®

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

NIFTY®

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

NIFTY®

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

NIFTY®

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