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D-81649002AMP01FRDV

AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMP01FRDV
Basic UDI-DI: B-81649002AMP01FRDV
Reference: AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AMP01DCWHF

AMP01D-AHG48E; AMP01D-AHG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AMP01DCWHF
Basic UDI-DI: B-81649002AMP01DCWHF
Reference: AMP01D-AHG48E; AMP01D-AHG96E
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AGAS01BNG6

AGAS01-AHG48E; AGAS01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AGAS01BNG6
Basic UDI-DI: B-81649002AGAS01BNG6
Reference: AGAS01-AHG48E; AGAS01D-AHG48E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AGAS01DATP8

AGAS01-AHG48E; AGAS01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002AGAS01DATP8
Basic UDI-DI: B-81649002AGAS01DATP8
Reference: AGAS01-AHG48E; AGAS01D-AHG48E
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY 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

Helicobacter Pylori IgG assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7O02FA
Basic UDI-DI: B-7O02FA
Reference: 7O02V1-B-EU, 7O02U1-B-EU, 7O02P1-B-EU
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

Treponema Pallidum Antibody assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7N02F5
Basic UDI-DI: B-7N02F5
Reference: 7N02V1-B-EU, 7N02U1-B-EU, 7N02P1-B-EU
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:29

Manufacturer products Authorised representative products Authorised representative actors View details

ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 48594036043990
Basic UDI-DI: B-48594036043990
Reference: OD-399/5ST
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 20:09

Manufacturer products View details

ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 48594036043983
Basic UDI-DI: B-48594036043983
Reference: OD-398/5ST
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 20:09

Manufacturer products View details

Geratherm® chlamydia check

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle useSterile

Manufacturer: Geratherm Medical GERMANY GmbH
Manufacturer SRN: DE-MF-000007307
UDI-DI: D-4018674GTCST01UUEW
Basic UDI-DI: B-4018674GTCST01UUEW
Reference: 9750000660
EMDN: W0105010107
EMDN description: CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:06

Manufacturer products View details

D-400-038-C-MAXQ3

BioGX Syphilis - OSR for BD MAX

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: BioGX B.V.
Manufacturer SRN: NL-MF-000031736
UDI-DI: D-400-038-C-MAXQ3
Basic UDI-DI: B-400-038-C-MAXQ3
Reference: 400-038-C-MAX
EMDN: W0105010305
EMDN description: SYPHILIS DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 11.07.2026 19:04

Manufacturer products View details

MONO-VIDITEST anti-Pseudomonas aeruginosa IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036044303
Basic UDI-DI: B-38594036044303
Reference: KZ-430-12
EMDN: W0105010901
EMDN description: PSEUDOMONAS AERUGINOSA ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:55

Manufacturer products View details

MONO-VIDITEST anti-Mycoplasma pneumoniae IgA

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036044020
Basic UDI-DI: B-38594036044020
Reference: KZ-402-12
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Mycoplasma pneumoniae IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036044013
Basic UDI-DI: B-38594036044013
Reference: KZ-401-12
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036044006
Basic UDI-DI: B-38594036044006
Reference: KZ-400-12
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Borrelia sp. IgG + VIsE

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043009
Basic UDI-DI: B-38594036043009
Reference: KZ-300-12
EMDN: W0105010603
EMDN description: LYME ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Borrelia sp. IgM

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036043016
Basic UDI-DI: B-38594036043016
Reference: KZ-301-12
EMDN: W0105010604
EMDN description: LYME ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Chlamydia pneumonieae IgA

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036042323
Basic UDI-DI: B-38594036042323
Reference: KZ-232-12
EMDN: W0105010114
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGA
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Chlamydia pneumonieae IgM

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036042316
Basic UDI-DI: B-38594036042316
Reference: KZ-231-12
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details

MONO-VIDITEST anti-Chlamydia pneumonieae IgG

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: VIDIA spol. s r.o.
Manufacturer SRN: CZ-MF-000036964
UDI-DI: 38594036042309
Basic UDI-DI: B-38594036042309
Reference: KZ-230-12
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Czechia
Authorised representative: -
Last updated: 11.07.2026 18:54

Manufacturer products View details