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10743816001133

BioSign H. pylori

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816001133
Basic UDI-DI: B-10743816001133
Reference: BSP-406WB-35
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

10743816000891

BioStrep A

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816000891
Basic UDI-DI: B-10743816000891
Reference: BSP-185-30
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

10743816000839

Status Strep A

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Princeton BioMeditech Corporation
Manufacturer SRN: US-MF-000048310
UDI-DI: 10743816000839
Basic UDI-DI: B-10743816000839
Reference: 34130
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

PerioPOC Pro

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GENSPEED Biotech
Manufacturer SRN: AT-MF-000013008
UDI-DI: 09120131770052
Basic UDI-DI: B-09120131770052
Reference: PPTK002
EMDN: W0105011699
EMDN description: BACTERIOLOGY - NA REAGENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 16:50

Manufacturer products View details

RevoDx Listeria monocytogenes qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717943
Basic UDI-DI: B-08683079717943
Reference: IP202253-100
EMDN: W0105011305
EMDN description: LISTERIA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:25

Manufacturer products View details

RevoDx Haemophilus influenzae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717936
Basic UDI-DI: B-08683079717936
Reference: IP202252-100
EMDN: W0105011610
EMDN description: HAEMOPHILUS INFLUENZAE - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:25

Manufacturer products View details

RevoDx Streptococcus agalactiae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717929
Basic UDI-DI: B-08683079717929
Reference: IP202251-100
EMDN: W0105011104
EMDN description: STREP. B DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:25

Manufacturer products View details

RevoDx Neisseria Meningitidis qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717776
Basic UDI-DI: B-08683079717776
Reference: IP202235-100
EMDN: W0105011611
EMDN description: NEISSERIA MENINGITIDIS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx Streptococcus pneumoniae qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717554
Basic UDI-DI: B-08683079717554
Reference: IP202214-100
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:24

Manufacturer products View details

RevoDx Staphyloccocus spp. qPCR Kit

IVD generalNot specifiedOn the market

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717509
Basic UDI-DI: B-08683079717509
Reference: IP202209-100
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:22

Manufacturer products View details

RevoDx Staphyloccocus aureus qPCR Kit

IVD generalNot specifiedOn the market

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717493
Basic UDI-DI: B-08683079717493
Reference: IP202208-100
EMDN: W0105011102
EMDN description: STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:22

Manufacturer products View details

TETANUS ELISA IgG

G1008