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CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906341
Basic UDI-DI: 50558449LPH022J9
Reference: CE-LPH 022
EMDN: W01060211
EMDN description: INV (16)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

Del(20q) Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906327
Basic UDI-DI: 50558449LPH020J5
Reference: CE-LPH 020
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

MLL (KMT2A) Breakapart Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906242
Basic UDI-DI: 50558449LPH013J8
Reference: CE-LPH 013
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

ATM Deletion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906204
Basic UDI-DI: 50558449LPH011J4
Reference: CE-LPH 011
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

BCR/ABL (ABL1) Translocation, Dual Fusion Probe

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906181
Basic UDI-DI: 50558449LPH007JD
Reference: CE-LPH 007
EMDN: W01060208
EMDN description: T (9;22)
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

Prenatal 13 and 21 Enumeration Probe kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Cytocell Limited
Manufacturer SRN: GB-MF-000016893
UDI-DI: 05055844906044
Basic UDI-DI: 50558449LPA003GL
Reference: CE-LPA 003
EMDN: W0106010304
EMDN description: PÄTAU SYNDROME
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 08:18

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit G99 SM FCL SE100/PE50

Universal Sequencing Reaction Kit

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

Manufacturer: Latvia MGI Tech
Manufacturer SRN: LV-MF-000017790
UDI-DI: 04751041380069
Basic UDI-DI: 475104138S-Kit9T
Reference: 940-000428-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Latvia
Authorised representative: -
Last updated: 31.07.2026 06:58

Manufacturer products View details

OzTGSO HLA MX11 Typing Kit

58010, 58011

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

Manufacturer: TBG Biotechnology Corp.
Manufacturer SRN: TW-MF-000029664
UDI-DI: 04718050362028
Basic UDI-DI: 47180503600580107Z
Reference: 58010, 58011
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 31.07.2026 06:34

Manufacturer products Authorised representative products Authorised representative actors View details

04260224890689

FastQ® B*27

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

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890689
Basic UDI-DI: 426022489FAQC01ACAF
Reference: 728208
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

04260224890658

HISTO TYPE Rainbow

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

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890658
Basic UDI-DI: 426022489HRTP01ACSC
Reference: 728220
EMDN: W0106010401
EMDN description: HLA-TYPING
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

04260224890580

FastQ® B*27 direct

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

Manufacturer: BAG Diagnostics GmbH
Manufacturer SRN: DE-MF-000024383
UDI-DI: 04260224890580
Basic UDI-DI: 426022489FAQD01ACAS
Reference: 728201
EMDN: W0106010499
EMDN description: POLYMORPHISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:44

Manufacturer products View details

XA AneuScore III

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813502
Basic UDI-DI: 42513158D-5613IVDLA
Reference: D-5613-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA AneuScore II

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813410
Basic UDI-DI: 42513158D-5609IVDM9
Reference: D-5609-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA X/Y

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813199
Basic UDI-DI: 42513158D-5608IVDM2
Reference: D-5608-100-OG
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XA X/Y/18

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813182
Basic UDI-DI: 42513158D-5606IVDLL
Reference: D-5606-100-TC
EMDN: W0106010306
EMDN description: MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XCE 12 blue

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813106
Basic UDI-DI: 42513158D-0812IVDJ8
Reference: D-0812-050-BL
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XCE 8 blue

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315813076
Basic UDI-DI: 42513158D-0808IVDK7
Reference: D-0808-050-BL
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XL MYC BA triple-color

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812994
Basic UDI-DI: 42513158D-6030IVDJE
Reference: D-6030-100-TC
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XL ROS1-GOPC BA

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812987
Basic UDI-DI: 42513158D-6029IVDL2
Reference: D-6029-100-OG
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:00

Manufacturer products View details

XL MYC BA

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: MetaSystems Probes GmbH
Manufacturer SRN: DE-MF-000006315
UDI-DI: 04251315812970
Basic UDI-DI: 42513158D-6023IVDJQ
Reference: D-6023-100-OG
EMDN: W01060205
EMDN description: C-MYC
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:59

Manufacturer products View details