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06950996061162

IVD Class CIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996061162
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DR10LH
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

06950996064521

IVD Class CIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996064521
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DRLH
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233014559
Basic UDI-DI: 06152338309JF
Reference: 8379-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-OCT3/4 Mouse Monoclonal Antibody [C-10]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233014481
Basic UDI-DI: 06152338306J9
Reference: 8288-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233013996
Basic UDI-DI: 06152338310HY
Reference: 8359-M250
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098] RTU, 10 capsules; 1 pack

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233013965
Basic UDI-DI: 06152338300HV
Reference: 8364-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-SALL4 Mouse Monoclonal Antibody [6E3]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011435
Basic UDI-DI: 06152338307JB
Reference: 8358-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-GATA3 Rabbit Monoclonal Antibody [QR018]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011428
Basic UDI-DI: 06152338298K3
Reference: 8357-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-SATB2 Rabbit Monoclonal Antibody [QR023]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011350
Basic UDI-DI: 06152338291JM
Reference: 8356-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233011312
Basic UDI-DI: 06152338304J5
Reference: 8337-M250
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MUC2 Mouse Monoclonal Antibody [CCP58]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010711
Basic UDI-DI: 06152338302HZ
Reference: 8305-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie® anti-MUC5AC Mouse Monoclonal Antibody [Nd-2]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010698
Basic UDI-DI: 06152338303J3
Reference: 8299-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-Ki67 Mouse Monoclonal Antibody [GM027]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010674
Basic UDI-DI: 06152338275JP
Reference: 8276-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-CD10 Rabbit Monoclonal Antibody [QR021]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010605
Basic UDI-DI: 06152338296JX
Reference: 8386-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010582
Basic UDI-DI: 06152338271JF
Reference: 8388-M250
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-CD3 Mouse Monoclonal Antibody [ZM45]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233010391
Basic UDI-DI: 06152338274JM
Reference: 8344-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek Genie®

Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177]

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: Sakura Finetek USA, Inc
Manufacturer SRN: US-MF-000022208
UDI-DI: 00615233000996
Basic UDI-DI: 06152338223J4
Reference: 8280-C010
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 16.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur fPSA

IVDR_67_TTN_DUB-C_C_KIT_Free Prostate-Specific Antigen

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414553344
Basic UDI-DI: 0405686901812VR
Reference: 10283414
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® CA 125II

IVDR_67_TTN_DUB-C_C_KIT_CA 125II

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461298
Basic UDI-DI: 0405686901800VJ
Reference: 10310443
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® CA 15-3®

IVDR_67_TTN_DUB-C_C_KIT_CA 15-3

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414461311
Basic UDI-DI: 0405686901801VL
Reference: 10327620
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details