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581 device results listed.

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Immunofluorescence Analyzer

OG-H180

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

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028192
Basic UDI-DI: 81649002OG-H1808X
Reference: OG-H180
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

Calprotectin Quantitative Test Kit (Time-Resolved FIA)