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04049095140648

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095140648
Basic UDI-DI: 4049095N082300000XC
Reference: NP0824
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 22:40

Manufacturer products View details

H.Pylori Antibody Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156250811
Basic UDI-DI: 6975156250000DZF
Reference: I021-N4002T-40
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156250903
Basic UDI-DI: 6975156250000DZF
Reference: I021-N4002-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

H.Pylori Antibody Rapid Test

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingSingle use

Manufacturer: Hangzhou Tongzhou Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000038774
UDI-DI: 06975156250910
Basic UDI-DI: 6975156250000DZF
Reference: I021-N4002-40
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

SIMPLE GDH / STICK GDH

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004082
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.15.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple / Stick Strep A

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004150
Basic UDI-DI: 84295779134XX
Reference: 9.134.040.15.000
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple / Stick Strep A

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004174
Basic UDI-DI: 84295779134XX
Reference: 9.134.020.15.000
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple / Stick Strep A

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004839
Basic UDI-DI: 84295779134XX
Reference: 9.134.040.71.000
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple H.pyl-Tf

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004846
Basic UDI-DI: 84295779231XW
Reference: 9.231.020.71.000
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

SIMPLE GDH / STICK GDH

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004891
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.71.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

SIMPLE GDH / STICK GDH

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007816
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.16.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

VIRAPID® HELICOBACTER PYLORI/TRANSFERRIN Ag

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007823
Basic UDI-DI: 84295779231XW
Reference: 9.23.1025.62.026 -
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple H.pyl-Tf

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007854
Basic UDI-DI: 84295779231XW
Reference: 9.231.020.15.000
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple H.pyl-Tf

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007861
Basic UDI-DI: 84295779231XW
Reference: 9.231.020.16.000
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple GDH-Toxins

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007878
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.15.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple GDH-Toxins

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007885
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.16.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple GDH-Toxins

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577007892
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.71.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple / Stick Strep A

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577119267
Basic UDI-DI: 84295779134XX
Reference: 9.134.020.00.000
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details