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680 device results listed.

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Oncobit PM Analyzer

1.0.0

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Oncobit AG
Manufacturer SRN: CH-MF-000037436
UDI-DI: 07649995954030
Basic UDI-DI: 7649995954PMAnalyzerGE
Reference: PM-2-00-00-3
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: MedEnvoy Global BV
Last updated: 30.06.2026 13:14

Manufacturer products Authorised representative products Authorised representative actors View details

Oncobit PM Analyzer

1.0.0

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Oncobit AG
Manufacturer SRN: CH-MF-000037436
UDI-DI: 07649995954016
Basic UDI-DI: 7649995954PMAnalyzerGE
Reference: PM-2-00-00-3
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Germany
Authorised representative: MedEnvoy Global BV
Last updated: 30.06.2026 13:14

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Gastric Cancer（Real Time PCR）

30 tests per kit

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

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703930109
Basic UDI-DI: 697070393GAC00182
Reference: GAC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 30.06.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）

30 tests per kit

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

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703930093
Basic UDI-DI: 697070393BRC001BU
Reference: BRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 30.06.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Colorectal Cancer（Real Time PCR）

30 tests per kit

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

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703930086
Basic UDI-DI: 697070393CRC001C9
Reference: CRC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 30.06.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for Methylated Genes of Lung Cancer（Real Time PCR）

30 tests per kit

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

Manufacturer: Excellen Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000010402
UDI-DI: 06970703930079
Basic UDI-DI: 697070393LUC001GX
Reference: LUC-PCR-30-CE
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 30.06.2026 08:19

Manufacturer products Authorised representative products Authorised representative actors View details

06959094212636

12 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094212636
Basic UDI-DI: B-06959094212636
Reference: 8.01.0165
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Northern Ireland
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06959094212483

12 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094212483
Basic UDI-DI: B-06959094212483
Reference: 8.01.20213X012E
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Northern Ireland
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06959094212384

24 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Amoy Diagnostics Co., LTD.
Manufacturer SRN: CN-MF-000021843
UDI-DI: 06959094212384
Basic UDI-DI: B-06959094212384
Reference: 8.0680701X024I
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Northern Ireland
Authorised representative: QbD RepS BV
Last updated: 29.06.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06959094211004

6 tests/kit