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92 device results listed.

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Control positivo en seco Crypto-Giardia-Entamoeba / Crypto-Giardia-Entamoeba Dry Positive Control

9.144.011.12.000

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003948
Basic UDI-DI: 8429577914412D9
Reference: 9.144.011.12.000
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

CONTROL POSITIVO EN SECO ROTA-ADENO-NORO || DRY POSITIVE CONTROL ROTA-ADENO-NORO

9.050.XXX.12.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003481
Basic UDI-DI: 8429577905012CH
Reference: 9.050.011.12.000
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple RSV-RespirAdeno

9.110.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003269
Basic UDI-DI: 84295779110XH
Reference: 9.110.020.47.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple RSV-Flu A+B

9.081.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003245
Basic UDI-DI: 84295779081Y3
Reference: 9.081.020.47.000
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple RespirAdeno

9.091.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003238
Basic UDI-DI: 84295779091Y6
Reference: 9.091.020.46.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)

5.182.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003122
Basic UDI-DI: 84295775182XE
Reference: 5.182.096.88.000
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple Flu A+B

9.080.XX.YYY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003214
Basic UDI-DI: 84295779080XZ
Reference: 9.080.020.46.000
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple RSV

9.064.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003191
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.46.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple GDH-Toxins

9.065.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003054
Basic UDI-DI: 84295779065Y5
Reference: 9.065.020.20.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Simple Rota-Adeno-Noro

9.050.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003047
Basic UDI-DI: 84295779050XQ
Reference: 9.050.020.20.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

SIMPLE GDH / STICK GDH

9.045.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002828
Basic UDI-DI: 84295779045XX
Reference: 9.045.020.00.000
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

SIMPLE ROTA-ADENO / STICK ROTA-ADENO

9.024.XXX.YY.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577000862
Basic UDI-DI: 84295779024XP
Reference: 9.024.020.21.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

Real Respiratory Bacterial Panel 2 (B. pertussis, B. parapertussis, B. holmesii)

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577003139
Basic UDI-DI: 84295775182XE
Reference: 5.182.048.88.000
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

SIMPLE ROTA-ADENO / STICK ROTA-ADENO

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577002927
Basic UDI-DI: 84295779024XP
Reference: 9.024.020.15.000
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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: 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 RSV-Flu A+B

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004464
Basic UDI-DI: 84295779081Y3
Reference: 9.081.020.71.000
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple RSV

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004792
Basic UDI-DI: 84295779064Y3
Reference: 9.064.020.71.000
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details

Simple Flu A+B

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004822
Basic UDI-DI: 84295779080XZ
Reference: 9.080.020.71.000
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Authorised representative: -
Last updated: 16.06.2026 05:56

Manufacturer products View details