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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

17.07.2026 02:49

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Active filter:Manufacturer SRN:US-MF-000018839

581 device results listed.

Page 28 / 30

D-81649002AEBV01BNGJ

AEBV01-AHG48E; AEBV01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AEBV01BNGJ
Basic UDI-DI: B-81649002AEBV01BNGJ
Reference: AEBV01-AHG48E; AEBV01D-AHG48E
EMDN: W0105040403
EMDN description: EBV - 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-81649002ADZCOM01D7667

ADZCOM01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADZCOM01D7667
Basic UDI-DI: B-81649002ADZCOM01D7667
Reference: ADZCOM01D-AHG48E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
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-81649002ADV01EQC5

ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADV01EQC5
Basic UDI-DI: B-81649002ADV01EQC5
Reference: ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - 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-81649002ADV01DB5CX

ADV01D-AHG48E; ADV01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADV01DB5CX
Basic UDI-DI: B-81649002ADV01DB5CX
Reference: ADV01D-AHG48E; ADV01D-AHG96E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - 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-81649002ABPTS02JB59

ABPTS02-AHG48E/ ABPTS02-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ABPTS02JB59
Basic UDI-DI: B-81649002ABPTS02JB59
Reference: ABPTS02-AHG48E/ ABPTS02-AHG96E
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - 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

Multiplex Fluorescent Analyzer

-

IVD Class ANot specifiedOn the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173653022
Basic UDI-DI: 81017365OG-G2604E
Reference: OG-G260
EMDN: -
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Immunofluorescence Analyzer

-

IVD Class ANot specifiedOn the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173654708
Basic UDI-DI: 81649002OG-H10189
Reference: OG-H101
EMDN: -
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173655149
Basic UDI-DI: 81649002Mplex-M100RS
Reference: M-FLA-201-01
EMDN: -
EMDN description: FLOW CYTOMETRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173655187
Basic UDI-DI: 81649002Mplex-M100RS
Reference: M-FLA-202-01
EMDN: -
EMDN description: FLOW CYTOMETRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

-

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656818
Basic UDI-DI: B-00810173656818
Reference: 1CKMBB01
EMDN: -
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay)

-

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656825
Basic UDI-DI: B-00810173656825
Reference: 1CKMBB02
EMDN: -
EMDN description: CREATINE KINASE ISOENZYMES
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

-

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656832
Basic UDI-DI: B-00810173656832
Reference: 1CTNTB01
EMDN: -
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for High sensitivity Troponin T (Chemiluminescence Assay)

-

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656849
Basic UDI-DI: B-00810173656849
Reference: 1CTNTB02
EMDN: -
EMDN description: TROPONIN I/T
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay)

-

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656856
Basic UDI-DI: B-00810173656856
Reference: 1MYOB01
EMDN: -
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details