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Alpha-fetoprotein Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346314
Basic UDI-DI: B-10850076346314
Reference: CEAFP-301a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:39

Manufacturer products Authorised representative products Authorised representative actors View details

FREND PSA Plus

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540481
Basic UDI-DI: B-08809317540481
Reference: FRPS 025
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

SOFTEC Fecal Occult Blood Test (FOB Test)

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616046
Basic UDI-DI: B-08697962616046
Reference: SGGT-101
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:21

Manufacturer products View details

RapidFor™ CA 15-3 Rapid Test Kit (FIA)

VMPO84

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030219
Basic UDI-DI: B-08684595030219
Reference: VMPO84
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:13

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RapidFor™ CA19-9 Rapid Test Kit

VMPO60

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030011
Basic UDI-DI: B-08684595030011
Reference: VMPO60
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:12

Manufacturer products View details

RapidFor™ CEA Rapid Test Kit (FIA)

VMPO52

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250902
Basic UDI-DI: B-08683548250902
Reference: VMPO52
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

RapidFor™ AFP Rapid Test Kit (FIA)

VMPO51

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250896
Basic UDI-DI: B-08683548250896
Reference: VMPO51
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

RapidFor™ β2-Microglobulin Rapid Test Kit (FIA)

VMPO50

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548250889
Basic UDI-DI: B-08683548250889
Reference: VMPO50
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:10

Manufacturer products View details

RapidFor™ CEA Rapid Test Kit

VMD45

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941513
Basic UDI-DI: B-08683347941513
Reference: VMD45
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products View details

RapidFor™ AFP Rapid Test Kit

VMD44

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941506
Basic UDI-DI: B-08683347941506
Reference: VMD44
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:04

Manufacturer products View details

CA125 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359516761
Basic UDI-DI: 697015090000008GY
Reference: CMB0607
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359516778
Basic UDI-DI: 697015090000008GY
Reference: CMB0608
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

tPSA CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548410
Basic UDI-DI: 697015090000111GS
Reference: CMB0305
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

fPSA CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548519
Basic UDI-DI: 697015090000112GU
Reference: CMB0505
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

CEA CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548618
Basic UDI-DI: 697015090000007GW
Reference: CMB0205
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548694
Basic UDI-DI: 697015090000008GY
Reference: CMB0603
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

CA125 CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548717
Basic UDI-DI: 697015090000008GY
Reference: CMB0605
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

NSE CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548816
Basic UDI-DI: 697015090000013GR
Reference: CMB1105
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

AFP CLIA Microparticles

IVD Class CNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359548915
Basic UDI-DI: 697015090000006GU
Reference: CMB0105
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359549110
Basic UDI-DI: 697015090000012GP
Reference: CMB1005
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:38

Manufacturer products Authorised representative products Authorised representative actors View details