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IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111722158
Basic UDI-DI: 88001117IPBA01MA03WR
Reference: 11FLU30A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 12.07.2026 11:37

Manufacturer products Authorised representative products Authorised representative actors View details

Real SARS-CoV-2/Flu/RSV

5.237.XXX.88.ZZZ

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295775237XEGW
Basic UDI-DI: B-84295775237XEGW
Reference: 5.237.XXX.88.ZZZ
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

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STD Panel Strip

3.150.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773150WKFD
Basic UDI-DI: B-84295773150WKFD
Reference: 3.150.XXX.YY.ZZZ
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

Respiratory Bacterial Panel Strip

3.095.XXX.YY.ZZZ

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295773095X4FE
Basic UDI-DI: B-84295773095X4FE
Reference: 3.095.XXX.YY.ZZZ
EMDN: W0105070201
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:08

Manufacturer products View details

D-81649002CSTIZK01AKWVB

CSTIZK01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CSTIZK01AKWVB
Basic UDI-DI: B-81649002CSTIZK01AKWVB
Reference: CSTIZK01A-AHG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CRTI701ASJHB

CRTI701A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CRTI701ASJHB
Basic UDI-DI: B-81649002CRTI701ASJHB
Reference: CRTI701A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CRTI601ASBGE

CRTI601A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CRTI601ASBGE
Basic UDI-DI: B-81649002CRTI601ASBGE
Reference: CRTI601A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CGCT01ACLRC

CGCT01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CGCT01ACLRC
Basic UDI-DI: B-81649002CGCT01ACLRC
Reference: CGCT01A-AHG4E
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CFFCR01AJ45L

CFFCR01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CFFCR01AJ45L
Basic UDI-DI: B-81649002CFFCR01AJ45L
Reference: CFFCR01A-AHG4E
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AFR01EJB5

AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AFR01EJB5
Basic UDI-DI: B-81649002AFR01EJB5
Reference: AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ACOV03DXMV

ACOV03-AHG48E; ACOV03-AHG96E; ACOV03D-AHG48E; ACOV03D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ACOV03DXMV
Basic UDI-DI: B-81649002ACOV03DXMV
Reference: ACOV03-AHG48E; ACOV03-AHG96E; ACOV03D-AHG48E; ACOV03D-AHG96E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ACOV03DEUWD

ACOV03D-AHG48E; ACOV03D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ACOV03DEUWD
Basic UDI-DI: B-81649002ACOV03DEUWD
Reference: ACOV03D-AHG48E; ACOV03D-AHG96E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ACOV01DTMB

ACOV01-AHG48E; ACOV01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ACOV01DTMB
Basic UDI-DI: B-81649002ACOV01DTMB
Reference: ACOV01-AHG48E; ACOV01-AHG96E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ACAB04D5RDF

ACAB04D-BHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ACAB04D5RDF
Basic UDI-DI: B-81649002ACAB04D5RDF
Reference: ACAB04D-BHG48E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ACAB017M77

ACAB01-AHG48E; ACAB01-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ACAB017M77
Basic UDI-DI: B-81649002ACAB017M77
Reference: ACAB01-AHG48E; ACAB01-AHG96E
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002101A0227EYDUX7

101A0227EY

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002101A0227EYDUX7
Basic UDI-DI: B-81649002101A0227EYDUX7
Reference: 101A0227EY
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/InFluA/InFluB Antigen Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808155-1BE
Basic UDI-DI: B-808155-1BE
Reference: 808155-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808152-1AX
Basic UDI-DI: B-808152-1AX
Reference: 808152-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

SirYus Covidiag +

SirYus Covidiag +

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substances

Manufacturer: Innobiochips
Manufacturer SRN: FR-MF-000009584
UDI-DI: 37700267940128
Basic UDI-DI: B-37700267940128
Reference: 2009
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:50

Manufacturer products View details

SirYus Covidiag

SirYus Covidiag

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substances

Manufacturer: Innobiochips
Manufacturer SRN: FR-MF-000009584
UDI-DI: 37700267940050
Basic UDI-DI: B-37700267940050
Reference: 2001
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 11.07.2026 18:50

Manufacturer products View details