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Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICD-R635BWB
Basic UDI-DI: B-ICD-R635BWB
Reference: ICD-R635B
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-HP-602SZ
Basic UDI-DI: B-FI-HP-602SZ
Reference: FI-HP-602
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-R602FT
Basic UDI-DI: B-IHP-R602FT
Reference: IHP-R602
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-401SG
Basic UDI-DI: B-IHP-401SG
Reference: IHP-401
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-302SD
Basic UDI-DI: B-IHP-302SD
Reference: IHP-302
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICD-635B3B
Basic UDI-DI: B-ICD-635B3B
Reference: ICD-635B
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-CDG-602JG
Basic UDI-DI: B-FI-CDG-602JG
Reference: FI-CDG-602
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205166
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA106L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 21.07.2026 23:14

Manufacturer products View details

LYHER

IHP-402

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412615148
Basic UDI-DI: 697241261IHP-402DR
Reference: IHP-402-07
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IHP-602

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613564
Basic UDI-DI: 697241261IHP-602E3
Reference: IHP-602-07
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

04049095210549

RIDA®UNITY EHEC/EPEC

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210549
Basic UDI-DI: 4049095UN22050000PK
Reference: UN2205
EMDN: W0105011503
EMDN description: E. COLI DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 21.07.2026 23:00

Manufacturer products View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618941
Basic UDI-DI: 697241261IHP-602E3
Reference: IHP-602-25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618262
Basic UDI-DI: 697241261IHP-402DR
Reference: IHP-402-25
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 21.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440228387
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA101L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440228394
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA101H
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205197
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA106H
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205173
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA112L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205203
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA112H
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:52

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205180
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA113L
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

VIASURE Clostridium difficile toxins A+B Real Time PCR Detection Kit

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205210
Basic UDI-DI: 84354402_MDXGASTROB_CDAP6
Reference: VS-CDA113H
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details