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163 device results listed.

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Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii fecale) caseta

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080034
Basic UDI-DI: 5944759080VTENTG25FECB6FW
Reference: VT-ENT-25
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

D-697994388Ir0393PEK

FOB/TF Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0393PEK
Basic UDI-DI: B-697994388Ir0393PEK
Reference: Ir039
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood FIA Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB000FKQ5Q
Basic UDI-DI: B-697424646FOB000FKQ5Q
Reference: FOB-5012F
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
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

Faecal Occult Blood Rapid Test Kit(Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FOB000GCSL
Basic UDI-DI: B-697424646FOB000GCSL
Reference: FOB-5011/FOB-5012
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Bowel Health (FOB) Rapid Test

One+Step Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178341
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602H-01
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Ireland
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 10:56

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

NADAL® FOB Test

FOB Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-272001SF
Basic UDI-DI: B-nvm-272001SF
Reference: 272001
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

Lactose Detection Kit (Enzyme Cascade Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: D-CNMF000023810LDKCW024K9
Basic UDI-DI: B-CNMF000023810LDKCW024K9
Reference: CW024
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:06

Manufacturer products Authorised representative products Authorised representative actors View details

ZuhauseTEST Bowel Health (FOB) Rapid Test Cassette

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983199452
Basic UDI-DI: 6970277510014RYW
Reference: 600400
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.07.2026 22:56

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

RAID-CRC Screen

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437193
Basic UDI-DI: B-08437023437193
Reference: CRC-01-1230-01
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:01

Manufacturer products View details

TESTURGUT

TESTURGUT qPCR Kit

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437056
Basic UDI-DI: B-08437023437056
Reference: TUG-01-1024
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:01

Manufacturer products View details

RAID-Dx

RAID-Dx qPCR Kit HP

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437049
Basic UDI-DI: B-08437023437049
Reference: DX-02-2024-01-HP
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:01

Manufacturer products View details

RAID-Dx

RAID-Dx qPCR Kit LP

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437032
Basic UDI-DI: B-08437023437032
Reference: DX-02-1024-01-LP
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:01

Manufacturer products View details

RAID-CRC Symptomatic

RAID-CRC Symptomatic qPCR Kit

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437025
Basic UDI-DI: B-08437023437025
Reference: CRC-01-2250-01
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:01

Manufacturer products View details

RAID-CRC Screen

RAID-CRC SCREEN

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GOODGUT, SLU
Manufacturer SRN: ES-MF-000000229
UDI-DI: 08437023437018
Basic UDI-DI: B-08437023437018
Reference: CRC-01-1250-01
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 01:01

Manufacturer products View details

Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178358
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602H-02
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178365
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602H-05
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178372
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602H-10
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178389
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602AH-01
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178396
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602AH-02
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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

Bowel Health (FOB) Rapid Test

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983178402
Basic UDI-DI: 6970277510014RYW
Reference: TFO-N602AH-05
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: -
Safety summary (SSCP/SSP): RTD014601-SSP · Rev. 05
Authorised representative: MedNet EC-REP GmbH
Last updated: 07.07.2026 11:48

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