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IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 4bases SA
Manufacturer SRN: CH-MF-000042125
UDI-DI: 76404133800354
Basic UDI-DI: 764041338300X2Z
Reference: 3006
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: 4bases Italia srl
Last updated: 03.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

Colosafe

Stool Preservation Solution

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041039
Basic UDI-DI: 6974591041002AS
Reference: KLM-100201
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:39

Manufacturer products Authorised representative products Authorised representative actors View details

EpiDirect® MLH1 Methylation qPCR Assay

MLH1 Methylation qPCR Assay

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915001417
Basic UDI-DI: 5713915ED002M2
Reference: 8401;8400
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

EpiDirect® MGMT Methylation qPCR Assay

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000434
Basic UDI-DI: 5713915ED001LY
Reference: 8300
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000410
Basic UDI-DI: 5713915PP004TK
Reference: 1500
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

PlentiPlex™ KIT Mastocytosis qPCR Assay

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000373
Basic UDI-DI: 5713915PP001TD
Reference: 7032
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Denmark
Authorised representative: -
Last updated: 02.07.2026 04:52

Manufacturer products View details

XL CDKN2A/9q22

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812543
Basic UDI-DI: 42513158D-5118IVDKC
Reference: D-5118-100-OG
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 21:52

Manufacturer products View details

ipsogen IDH1 RGQ PCR Kit

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsKitMicrobial substancesProfessional testingReagent

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228053262
Basic UDI-DI: 4053228RIDH100000000001BZ
Reference: 675223
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 01.07.2026 19:24

Manufacturer products View details

SALSA MLPA Probemix ME032 UPD7-UPD14

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211482427
Basic UDI-DI: 872021148ME032ZH
Reference: ME032-025R
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:44

Manufacturer products View details

SALSA MLPA Probemix P017 MEN1

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MRC Holland B.V.
Manufacturer SRN: NL-MF-000000437
UDI-DI: 08720211480317
Basic UDI-DI: 872021148P0175M
Reference: P017-025R
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: -
Last updated: 01.07.2026 03:42

Manufacturer products View details

EasyPGX ready JAK2