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KIT qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS013VARA
Basic UDI-DI: B-5713915SS013VARA
Reference: 1154; 1846
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

PIK3CA qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS010V4Q3
Basic UDI-DI: B-5713915SS010V4Q3
Reference: 5585; 5586; 5587; 5590; 5591; 5592; 5600; 5601
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:49

Manufacturer products View details

NRAS qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS007VFRZ
Basic UDI-DI: B-5713915SS007VFRZ
Reference: 1771;-76,-81,86,96;1801,-11,-16,-21,-26;2000,-05,-10,-15,-25,-30,-40,-45,-50,-55
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

EGFR qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS004V9QS
Basic UDI-DI: B-5713915SS004V9QS
Reference: 5675;5686;5550;5366;5575;5391;5545;5361;5555;5371;5540;5351;5570;5386;5560;5376;5565;5381;3075;5408
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

KRAS qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS005VBRF
Basic UDI-DI: B-5713915SS005VBRF
Reference: 1900;1701;1905;1706;1910;1711;1915;1716;1925;1726;1930;1731;1940;1741;1945;1746;1955;1756;1960;1761
EMDN: W01060202
EMDN description: K-RAS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

EGFR qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS003V7QH
Basic UDI-DI: B-5713915SS003V7QH
Reference: 5670;5681;2085;2081;3027;3071;2075;2071;2095;2091;2065;2061;3025;3021;3005;3001;3015;3011;3077;5398
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

BRAF qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS002V5Q8
Basic UDI-DI: B-5713915SS002V5Q8
Reference: 5525; 5530; 5535; 5336; 5341; 5346
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

BRAF qPCR Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915SS001V3PX
Basic UDI-DI: B-5713915SS001V3PX
Reference: 1398;1402;1400;1831;1836;1841
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

48 Rxns/kit ，96 Rxns/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: D-529012PL
Basic UDI-DI: B-529012PL
Reference: 529012/529013
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 17.07.2026 02:37

Manufacturer products Authorised representative products Authorised representative actors View details

iDNA PGx CNS kit

Ref. 002

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ
Manufacturer SRN: GR-MF-000033624
UDI-DI: D-5200423500223L4
Basic UDI-DI: B-5200423500223L4
Reference: Ref.002
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 17.07.2026 02:36

Manufacturer products View details

iDNA Cardio Health

Ref.005

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ
Manufacturer SRN: GR-MF-000033624
UDI-DI: 52004235002160
Basic UDI-DI: B-52004235002160
Reference: Ref.005
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 17.07.2026 02:34

Manufacturer products View details

Xpert® NPM1 Mutation

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940008390
Basic UDI-DI: B-07332940008390
Reference: GXNPM1-CE-10
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Bladder Cancer Monitor

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002282
Basic UDI-DI: B-07332940002282
Reference: GXBLAD-CM-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® Bladder Cancer Detection

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002268
Basic UDI-DI: B-07332940002268
Reference: GXBLAD-CD-CE-10
EMDN: W01060215
EMDN description: BLADDER CANCER DETECTION / MONITORING
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert® FII & FV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940000240
Basic UDI-DI: B-07332940000240
Reference: GXFIIFV-10
EMDN: W0106010115
EMDN description: COMBINED FACTOR II / FACTOR V LEIDEN
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

384 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584312
Basic UDI-DI: B-06974968584312
Reference: L000162-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

96 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584305
Basic UDI-DI: B-06974968584305
Reference: L000161-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

64 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584299
Basic UDI-DI: B-06974968584299
Reference: L000160-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

48tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584282
Basic UDI-DI: B-06974968584282
Reference: L000159-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

32 tests/kit (Pre-packaged)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968584275
Basic UDI-DI: B-06974968584275
Reference: L000158-P
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details