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D-IM4407040JD

Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407040JD
Basic UDI-DI: B-IM4407040JD
Reference: IM4407040
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406041J8

Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406041J8
Basic UDI-DI: B-IM4406041J8
Reference: IM4406041
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406040J6

Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406040J6
Basic UDI-DI: B-IM4406040J6
Reference: IM4406040
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403041HK

Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403041HK
Basic UDI-DI: B-IM4403041HK
Reference: IM4403041
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403040HH

Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403040HH
Basic UDI-DI: B-IM4403040HH
Reference: IM4403040
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402041HC

Mycoplasma Pneumoniae IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402041HC
Basic UDI-DI: B-IM4402041HC
Reference: IM4402041
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402040HA

Mycoplasma Pneumoniae IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402040HA
Basic UDI-DI: B-IM4402040HA
Reference: IM4402040
EMDN: W0105010899
EMDN description: MYCOPLASMA / UREAPLASMA REAGENTS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

Lyme IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILY-R402MA
Basic UDI-DI: B-ILY-R402MA
Reference: ILY-R402
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILEP-R402AD
Basic UDI-DI: B-ILEP-R402AD
Reference: ILEP-R402
EMDN: W0105011704
EMDN description: LEPTOSPIRA
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:12

Manufacturer products Authorised representative products Authorised representative actors View details

ILE-HEL036B

Helicobacter pylori IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-HEL036B
Basic UDI-DI: B-ILE-HEL036B
Reference: ILE-HEL03
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

ILE-HEL0269

Helicobacter pylori IgA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-HEL0269
Basic UDI-DI: B-ILE-HEL0269
Reference: ILE-HEL02
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

ILE-HEL0167

Helicobacter pylori IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-HEL0167
Basic UDI-DI: B-ILE-HEL0167
Reference: ILE-HEL01
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

ILE-DIP016B

Diphtheria Toxid IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-DIP016B
Basic UDI-DI: B-ILE-DIP016B
Reference: ILE-DIP01
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:10

Manufacturer products View details

H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-R402FH
Basic UDI-DI: B-IHP-R402FH
Reference: IHP-R402
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-R302FC
Basic UDI-DI: B-IHP-R302FC
Reference: IHP-R302
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhea Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IGO-R502EQ
Basic UDI-DI: B-IGO-R502EQ
Reference: IGO-R502
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Abortus Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IBA-R40268
Basic UDI-DI: B-IBA-R40268
Reference: IBA-R402
EMDN: W0105011701
EMDN description: BRUCELLA
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

Hp Ab Helicobacter Pylori Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HpAb706-AEUN
Basic UDI-DI: B-HpAb706-AEUN
Reference: HpAb706-AE10Y, HpAb706-AE10N, HpAb706-AE20Y, HpAb706-AE20N
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 01:02

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD158XV
Basic UDI-DI: B-GKPD158XV
Reference: GKPD158
EMDN: W0105010202
EMDN description: GONOCOCCAL ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD157XT
Basic UDI-DI: B-GKPD157XT
Reference: GKPD157
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details