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620 device results listed.

Page 9 / 31

M. pneumoniae Ag Rapid Test Cassette (Swab)

GCMP-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMP-502aHGSP
Basic UDI-DI: B-GCMP-502aHGSP
Reference: GCMP-502a
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

M. pneumonia IgM Rapid Test Cassette (Serum/Plasma)

GCMP(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMP(IgM)-302aHGWR
Basic UDI-DI: B-GCMP(IgM)-302aHGWR
Reference: GCMP(IgM)-302a
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCMON-425a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-425aHG9Q
Basic UDI-DI: B-GCMON-425aHG9Q
Reference: GCMON-425a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

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Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMON-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-402aHG8D
Basic UDI-DI: B-GCMON-402aHG8D
Reference: GCMON-402a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma)

GCMON-325a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMON-325aHG9B
Basic UDI-DI: B-GCMON-325aHG9B
Reference: GCMON-325a
EMDN: W0105099003
EMDN description: MONONUCLEOSIS (EBV) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Ag Rapid Test Cassette (Swab)

GCMKP-502b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMKP-502bHG79
Basic UDI-DI: B-GCMKP-502bHG79
Reference: GCMKP-502b
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCMKP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMKP-402aHG6P
Basic UDI-DI: B-GCMKP-402aHG6P
Reference: GCMKP-402a
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma)

GCMAL(pf/pv Ab)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pvAb)-402aHG7N
Basic UDI-DI: B-GCMAL(pf/pvAb)-402aHG7N
Reference: GCMAL(pf/pv Ab)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma)

GCMAL(pf/pv Ab)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pvAb)-302aHG79
Basic UDI-DI: B-GCMAL(pf/pvAb)-302aHG79
Reference: GCMAL(pf/pv Ab)-302a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pv)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pv)-402aHGG2
Basic UDI-DI: B-GCMAL(pf/pv)-402aHGG2
Reference: GCMAL(pf/pv)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pf/pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pf/pan)-402aHGAD
Basic UDI-DI: B-GCMAL(pf/pan)-402aHGAD
Reference: GCMAL(pf/pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pan Ag Rapid Test Cassette (Whole Blood)

GCMAL(pan)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(pan)-402aHG2H
Basic UDI-DI: B-GCMAL(pan)-402aHG2H
Reference: GCMAL(pan)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Pf Ag Rapid Test Cassette (Whole Blood)

GCMAL(Pf)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCMAL(Pf)-402aHGKG
Basic UDI-DI: B-GCMAL(Pf)-402aHGKG
Reference: GCMAL(Pf)-402a
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCLEP(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCLEP(IgG/IgM)-402aHG8L
Basic UDI-DI: B-GCLEP(IgG/IgM)-402aHG8L
Reference: GCLEP(IgG/IgM)-402a
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-T402aHGQK
Basic UDI-DI: B-GCKal-T402aHGQK
Reference: GCKal-T402a
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCKal-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-402aHGWR
Basic UDI-DI: B-GCKal-402aHGWR
Reference: GCKal-402a
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma)

GCKal-401a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCKal-401aHGWJ
Basic UDI-DI: B-GCKal-401aHGWJ
Reference: GCKal-401a
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCHV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHV(IgM)-402aHGY5
Basic UDI-DI: B-GCHV(IgM)-402aHGY5
Reference: GCHV(IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCHV(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHV(IgG/IgM)-402aHGXA
Basic UDI-DI: B-GCHV(IgG/IgM)-402aHGXA
Reference: GCHV(IgG/IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

GCHSV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHSV(IgM)-402aHGGF
Basic UDI-DI: B-GCHSV(IgM)-402aHGGF
Reference: GCHSV(IgM)-402a
EMDN: W0105040304
EMDN description: HSV 1+2 IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details