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05061059980021

ZENA MAX Respiratory Panel 3 SARS-CoV-2, Influenza A&B and H1N1 Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980021
Basic UDI-DI: B-05061059980021
Reference: KD146103M-100
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

05061059980014

ZENA MAX Respiratory Panel 2 SARS-CoV-2, Influenza A & B and RSB A&B Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980014
Basic UDI-DI: B-05061059980014
Reference: KD146102M-100
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

05061059980007

ZENA MAX Respiratory Panel 1 SARS-CoV-2, Influenza A and B Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980007
Basic UDI-DI: B-05061059980007
Reference: KD146101M-100
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

05060972700006

YouSeq SARS-CoV-2 Multiplex qRT-PCR kit

IVD generalIVDDNo longer on the marketKitProfessional testingReagent

Manufacturer: YouSeq Ltd
Manufacturer SRN: GB-MF-000033902
UDI-DI: 05060972700006
Basic UDI-DI: B-05060972700006
Reference: YS-qPX-CVD19-002-CE
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: Casus Consulting Limited
Last updated: 02.08.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

T-SPOT.CMV

CMV.400

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000407
Basic UDI-DI: B-05051716000407
Reference: CMV.400
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Wallac Oy
Last updated: 02.08.2026 15:51

Manufacturer products Authorised representative products Authorised representative actors View details

T-SPOT.COVID

COV.435/300

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Oxford Immunotec Ltd
Manufacturer SRN: GB-MF-000004429
UDI-DI: 05051716000193
Basic UDI-DI: B-05051716000193
Reference: COV.435/300
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Netherlands
Authorised representative: Oxford Immunotec (Ireland) Ltd
Last updated: 02.08.2026 15:51

Manufacturer products Authorised representative products Authorised representative actors View details

Positive Control Flu

IVD generalIVDDOn the marketAnimal tissuesReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815071110
Basic UDI-DI: B-04987815071110
Reference: ACPC7111
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Latvia
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia hMPV Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815016715
Basic UDI-DI: B-04987815016715
Reference: CAHM1671
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Belgium
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:45

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia hMPV 20T/Box

IVD generalNot specifiedOn the marketSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815016708
Basic UDI-DI: B-04987815016708
Reference: CAHM1670
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Mycoplasma 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815015718
Basic UDI-DI: B-04987815015718
Reference: CAMP1571
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Strep A 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815011703
Basic UDI-DI: B-04987815011703
Reference: CAST1170
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia RSV Neo Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815009717
Basic UDI-DI: B-04987815009717
Reference: CARS0971
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia RSV Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815009700
Basic UDI-DI: B-04987815009700
Reference: CARS0970
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Flu Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815005702
Basic UDI-DI: B-04987815005702
Reference: CAFL0570
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Adeno Neo Test Plate 10T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815003715
Basic UDI-DI: B-04987815003715
Reference: CAAD0371
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

Capilia Adeno Neo 20T/Box

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: TAUNS Laboratories, Inc.
Manufacturer SRN: JP-MF-000007041
UDI-DI: 04987815003708
Basic UDI-DI: B-04987815003708
Reference: CAAD0370
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 02.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

04897116730039

INDICAID COVID-19 RAPID ANTIGEN TEST

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: 04897116730039
Basic UDI-DI: B-04897116730039
Reference: 2110200
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.08.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920411

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920411
Basic UDI-DI: B-04897036920411
Reference: 92042
EMDN: W0105041002
EMDN description: SCREENING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920404

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920404
Basic UDI-DI: B-04897036920404
Reference: 92041
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920398

48 tests

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920398
Basic UDI-DI: B-04897036920398
Reference: 92040
EMDN: W0105041003
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 02.08.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details