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MYCOPLASMA PNEUMONIAE VIRCLIA® IgG MONOTEST

VCM062

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326138
Basic UDI-DI: 843604032VCM06201CR
Reference: VCM062
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® UREAPLASMA UREALYTICUM DNA CONTROL

MBC112

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322697
Basic UDI-DI: 843604032MBC1120123
Reference: MBC112
EMDN: W010501080303
EMDN description: UREAPLASMA DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® MYCOPLASMA GENITALIUM DNA CONTROL

MBC085

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322338
Basic UDI-DI: 843604032MBC085013Q
Reference: MBC085
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® MYCOPLASMA HOMINIS DNA CONTROL

MBC084

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040322321
Basic UDI-DI: 843604032MBC084013K
Reference: MBC084
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

AMPLIRUN® MYCOPLASMA PNEUMONIAE DNA CONTROL

MBC035

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040321850
Basic UDI-DI: 843604032MBC035012M
Reference: MBC035
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-25DN
Basic UDI-DI: B-EBX-039-25DN
Reference: EBX-039-25
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-10049
Basic UDI-DI: B-EBX-039-10049
Reference: EBX-039-100
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

EurobioPlex Streptocoque Groupe B (SGB/Streptococcus agalactiae)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-EBX-039-50DM
Basic UDI-DI: B-EBX-039-50DM
Reference: EBX-039-50
EMDN: W0105011299
EMDN description: STAPHYLOCOCCI REAGENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 31.07.2026 22:47

Manufacturer products View details

06955792743700

Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792743700
Basic UDI-DI: 69557927S3354E000001TQ
Reference: S3354E-48
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Chlamydia pn. IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715788
Basic UDI-DI: 692591270100GN
Reference: C88014M-L
EMDN: W0105010116
EMDN description: CHLAMYDIA PNEUMONIAE ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Chlamydia pn. IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715771
Basic UDI-DI: 692591270099HW
Reference: C88013G-L
EMDN: W0105010115
EMDN description: CHLAMYDIA PNEUMONAIE ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Mycoplasma pn. IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715764
Basic UDI-DI: 692591270094HL
Reference: C88004M-L
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Mycoplasma pn. IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715757
Basic UDI-DI: 692591270093HJ
Reference: C88003G-L
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Anti-TP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715603
Basic UDI-DI: 692591270114GZ
Reference: C88049-L
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080126
Basic UDI-DI: 5944759080VTCDABGDH25B6X8
Reference: VT-CDABGDH-25
EMDN: W0105011803
EMDN description: C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)

HELICOBACTER PYLORI AG RAPID TEST CASSETTE (FECES)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080003
Basic UDI-DI: 5944759080VTHPG25STO1B6H5
Reference: VT-HPG-25
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

PreventID® H. pylori

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015456
Basic UDI-DI: B-04050598015456
Reference: KST18116GP.05
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

STREPTOCOCCAL GROUPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013036
Basic UDI-DI: 5032384StrepGroupingKitQQ
Reference: DR0585A
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTOCOCCAL GROUPING REAGENT A

OXOID STREPTOCOCCAL GROUPING REAGENTS

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013043
Basic UDI-DI: 5032384StrepGroupLatexPP
Reference: DR0586G
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details

E. COLI O157 TEST KIT

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Oxoid Ltd
Manufacturer SRN: GB-MF-000016914
UDI-DI: 05032384013142
Basic UDI-DI: 5032384Ecoli5W
Reference: DR0620M
EMDN: W0105011501
EMDN description: E. COLI DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 31.07.2026 13:07

Manufacturer products Authorised representative products Authorised representative actors View details