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837 device results listed.

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MicroSight® MSI 1-Step HRM Analysis

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 05713915000441
Basic UDI-DI: 5713915MS001SZ
Reference: 7201
EMDN: W01060214
EMDN description: COLORECTAL CANCER (MSI-H / DMMR)
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

Idylla™ CDx MSI Test

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 15415219001328
Basic UDI-DI: 5415219A0220BV
Reference: A0220/6
EMDN: W01060214
EMDN description: COLORECTAL CANCER (MSI-H / DMMR)
First on market country: Belgium
Authorised representative: -
Last updated: 02.07.2026 04:05

Manufacturer products View details

BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906501
Basic UDI-DI: 50558449LPH038JQ
Reference: CE-LPH 038
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 02.07.2026 01:47

Manufacturer products Authorised representative products Authorised representative actors 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

Droplex KRAS Mutation Test v3

CD021

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Gencurix, Inc.
Manufacturer SRN: KR-MF-000034097
UDI-DI: 08800087700181
Basic UDI-DI: 88000877KRV3CD021DR
Reference: CD021
EMDN: W01060202
EMDN description: K-RAS
First on market country: France
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 01.07.2026 05:32

Manufacturer products Authorised representative products Authorised representative actors 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