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77 device results listed.

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EXTEL HEMO・AUTO HS Latex

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Canon Medical Diagnostics Corporation
Manufacturer SRN: JP-MF-000020364
UDI-DI: 04987295655534
Basic UDI-DI: 4987295BU001ZR
Reference: 65553
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

FIT Hemoglobin AA01

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

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274139352
Basic UDI-DI: 4987274W0102039013HBR02YB
Reference: 913935
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:32

Manufacturer products Authorised representative products Authorised representative actors View details

FIT Hemoglobin NS-Prime

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

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274108693
Basic UDI-DI: 4987274W0102039013HBR01Y9
Reference: 910869
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

OC-Light™ S FIT Test Strips

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026207339
Basic UDI-DI: 4987026TD-OCLSZW
Reference: V-PC52
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

OC-SENSOR FIT Buffer (for OC-SENSOR io, Micro)

OC-SENSOR Reagent Family

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026117294
Basic UDI-DI: 4987026TD-OCHBYG
Reference: V-PH46
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Quantitative Detection Kit (Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765606
Basic UDI-DI: B-06971348765606
Reference: MF-126-25
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Diagnostic Kit

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765576
Basic UDI-DI: B-06971348765576
Reference: MF-74-25
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Quantitative Detection Kit (Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348763237
Basic UDI-DI: B-06971348763237
Reference: MF-126-20
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Diagnostic Kit

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760731
Basic UDI-DI: B-06971348760731
Reference: MF-74-20
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

FOB-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673075200
Basic UDI-DI: B-08431673075200
Reference: TK1107185
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:16

Manufacturer products View details

FOB-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673075156
Basic UDI-DI: B-08431673075156
Reference: MI1107186
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: -
Last updated: 22.07.2026 00:33

Manufacturer products View details

FOB-TURBI

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673074937
Basic UDI-DI: B-08431673074937
Reference: MI1107185
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: -
Last updated: 22.07.2026 00:33

Manufacturer products View details

FOB Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840303186
Basic UDI-DI: B-69743840303186
Reference: 3040101
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:10

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood(FOB) Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB001GESV
Basic UDI-DI: B-697424646FOB001GESV
Reference: FOB-5011/FOB-5012
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test

VTFO

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210876
Basic UDI-DI: B-06937339210876
Reference: VTFO-U602C
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-494K

Fecal Occult Blood Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-494K
Basic UDI-DI: B-TD-HNKX-CED-494K
Reference: /
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-90502HE

Fecal Occult Blood Rapid Test（Colloidal Gold）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-90502HE
Basic UDI-DI: B-90502HE
Reference: /
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 12.07.2026 20:55

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

08435287111910

FECAL OCCULT BLOOD (FOB)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287111910
Basic UDI-DI: B-08435287111910
Reference: 12325
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:46

Manufacturer products View details

06979355923569

Fecal Occult Blood (FOB) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: 06979355923569
Basic UDI-DI: B-06979355923569
Reference: 100 tests/kit
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 07.07.2026 02:12

Manufacturer products Authorised representative products Authorised representative actors View details