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581 device results listed.

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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: 00810173656863
Basic UDI-DI: B-00810173656863
Reference: 1MYOB02
EMDN: -
EMDN description: MYOGLOBIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

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Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656870
Basic UDI-DI: B-00810173656870
Reference: 1TM3B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656887
Basic UDI-DI: B-00810173656887
Reference: 1TM7B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656894
Basic UDI-DI: B-00810173656894
Reference: 1TM6B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

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Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656900
Basic UDI-DI: B-00810173656900
Reference: 1AA15B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656917
Basic UDI-DI: B-00810173656917
Reference: 1GF3B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656924
Basic UDI-DI: B-00810173656924
Reference: 1TM2B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)

IVD generalNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656931
Basic UDI-DI: B-00810173656931
Reference: 2HPV18A01
EMDN: -
EMDN description: PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.07.2026 09:50

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Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)

IVD generalNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656948
Basic UDI-DI: B-00810173656948
Reference: 2HPV29A01
EMDN: -
EMDN description: OTHER HPV - NA REAGENTS
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Analysis Kit for Six Cytokines (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656955
Basic UDI-DI: B-00810173656955
Reference: 1CK6B01
EMDN: -
EMDN description: LYMPHOKINES /IMMUNMODULATORS - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 09:50

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Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656962
Basic UDI-DI: B-00810173656962
Reference: 1IF4B01
EMDN: -
EMDN description: MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER
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

Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656979
Basic UDI-DI: B-00810173656979
Reference: 2RET9A01
EMDN: -
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
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

Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)

IVD generalNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656986
Basic UDI-DI: B-00810173656986
Reference: 2RYT8A01
EMDN: -
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
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

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173656993
Basic UDI-DI: B-00810173656993
Reference: N7001C
EMDN: -
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
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

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

IVD generalNot specifiedOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173657006
Basic UDI-DI: B-00810173657006
Reference: N7001D
EMDN: -
EMDN description: MONOGENETIC DISORDERS TESTS - OTHER
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

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)

GCHCV-302a

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028482
Basic UDI-DI: B-00816490028482
Reference: GCHCV-302a
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)

GCHCV-402a

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028475
Basic UDI-DI: B-00816490028475
Reference: GCHCV-402a
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-Held Immunofluorescence

OG-G300

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028444
Basic UDI-DI: 81649002OG-G3008A
Reference: OG-G300
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Immunofluorescence Analyzer

OG-G200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028437
Basic UDI-DI: 81649002OG-G20085
Reference: OG-G200
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details

Mini Immunofluorescence Analyzer

OG-H100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028420
Basic UDI-DI: 81649002OG-H10087
Reference: OG-H100
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.07.2026 12:44

Manufacturer products Authorised representative products Authorised representative actors View details