EUDAMED Device Search

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-602j

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602jHGWY
Basic UDI-DI: B-GEFOB-602jHGWY
Reference: GEFOB-602j
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-602c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602cHGVV
Basic UDI-DI: B-GEFOB-602cHGVV
Reference: GEFOB-602c
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-602b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEFOB-602bXK
Basic UDI-DI: B-GEFOB-602bXK
Reference: GEFOB-602b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-602b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602bHGVQ
Basic UDI-DI: B-GEFOB-602bHGVQ
Reference: GEFOB-602b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-602Cb

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEFOB-602CbSD
Basic UDI-DI: B-GEFOB-602CbSD
Reference: GEFOB-602Cb
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-602Cb

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-602CbHG2V
Basic UDI-DI: B-GEFOB-602CbHG2V
Reference: GEFOB-602Cb
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-601c

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-601cHGVN
Basic UDI-DI: B-GEFOB-601cHGVN
Reference: GEFOB-601c
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-601b

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEFOB-601bXG
Basic UDI-DI: B-GEFOB-601bXG
Reference: GEFOB-601b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-601b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-601bHGVH
Basic UDI-DI: B-GEFOB-601bHGVH
Reference: GEFOB-601b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

GEFOB-601Cb

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-601CbHG2J
Basic UDI-DI: B-GEFOB-601CbHG2J
Reference: GEFOB-601Cb
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Bladder Tumor Antigen Rapid Test Cassette (Urine)

GEBTA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEBTA-102aHGSW
Basic UDI-DI: B-GEBTA-102aHGSW
Reference: GEBTA-102a
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FOB-F06aBM
Basic UDI-DI: B-FOB-F06aBM
Reference: FOB-F06a
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FOB-F02aB9
Basic UDI-DI: B-FOB-F02aB9
Reference: FOB-F02a
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-FIMF16823FOBxxTESTSX7

FOB test

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823FOBxxTESTSX7
Basic UDI-DI: B-FIMF16823FOBxxTESTSX7
Reference: FOBxxTEST-S
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

D-FIMF16823FOBxxKITSHP

FOB Test kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823FOBxxKITSHP
Basic UDI-DI: B-FIMF16823FOBxxKITSHP
Reference: FOBxxKIT-S
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

D-FIMF16823FOBTUBS42

FOB tube

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF16823FOBTUBS42
Basic UDI-DI: B-FIMF16823FOBTUBS42
Reference: FOBTUB-S
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 21:32

D-FIMF168232020xxTESTPY

FOB test

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF168232020xxTESTPY
Basic UDI-DI: B-FIMF168232020xxTESTPY
Reference: 20-20-xxTEST
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 13.07.2026 21:32

D-FIMF168232020xxFOBMZ

FOB test kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF168232020xxFOBMZ
Basic UDI-DI: B-FIMF168232020xxFOBMZ
Reference: 20-20-xxFOB
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 13.07.2026 21:32

D-FIMF168232020TUBZB

FOB tube

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Salofa Oy
Manufacturer SRN: FI-MF-000016823
UDI-DI: D-FIMF168232020TUBZB
Basic UDI-DI: B-FIMF168232020TUBZB
Reference: 20-20TUB
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 13.07.2026 21:32