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496 device results listed.

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08800204300638

RADI Malaria Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300638
Basic UDI-DI: B-08800204300638
Reference: RB007
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:15

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300584

CHAMP Malaria P.f Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300584
Basic UDI-DI: B-08800204300584
Reference: CB001
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300263

RADI Kala-azar (Leishmania) Detection KIT

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300263
Basic UDI-DI: B-08800204300263
Reference: RB003
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Toxoplasma IgG (Toxo G)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600123
Basic UDI-DI: 0405686900810VE
Reference: 10995699
EMDN: W0105050102
EMDN description: TOXOPLASMA ANTIBODY IGG
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Toxoplasma IgM (Toxo M)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600147
Basic UDI-DI: 0405686901825W2
Reference: 10995701
EMDN: W0105050103
EMDN description: TOXOPLASMA ANTIBODY IGM
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 09.07.2026 22:44

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens Toxoplasma gondii qPCR Kit

LYO149WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808455
Basic UDI-DI: B-08685115808455
Reference: LYO149
EMDN: W0105050105
EMDN description: TOXOPLASMA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

RapidFor™ Entamoeba histolytica Test Kit

VMD100TD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115800589
Basic UDI-DI: B-08685115800589
Reference: VMD100
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:22

Manufacturer products View details

RapidFor™ Giardia lamblia (FIA)

VMPO107GAD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277655
Basic UDI-DI: B-08684998277655
Reference: VMPO107
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

LyoSens Trichomonas vaginalis qPCR Kit

LYO59WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275743
Basic UDI-DI: B-08684998275743
Reference: LYO59
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

RapidFor™ Giardia lamblia (FIA)

VMPO107GD

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039182
Basic UDI-DI: B-08684595039182
Reference: VMPO107
EMDN: W0105050208
EMDN description: GIARDIA LAMBLIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™ Entamoeba Rapid Test Kit (FIA)

VMPO106

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039175
Basic UDI-DI: B-08684595039175
Reference: VMPO106GD
EMDN: W0105050201
EMDN description: ENTAMOEBA HISTOLYTICA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™ Cryptosporidium Parvum (Crypto) Rapid Test Kit (FIA)

VMPO105

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039168
Basic UDI-DI: B-08684595039168
Reference: VMPO105GD
EMDN: W0105050207
EMDN description: CRYPTOSPORIDIUM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™ Leishmenia Ab Rapid Test Kit

VMD113

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030516
Basic UDI-DI: B-08684595030516
Reference: VMD113
EMDN: W0105050205
EMDN description: LEISHMANIA
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

RevoDx Entamoeba Histolytica qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215633
Basic UDI-DI: B-08684387215633
Reference: IP202438-25
EMDN: W0105050301
EMDN description: ENTAMOEBA HISTOLYTICA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:05

Manufacturer products View details

RevoDx Malaria qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213967
Basic UDI-DI: B-08684387213967
Reference: IP202455-100
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

RevoDx Malaria qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213950
Basic UDI-DI: B-08684387213950
Reference: IP202455-25
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:00

Manufacturer products View details

RevoDx Toxoplasma gondii qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213790
Basic UDI-DI: B-08684387213790
Reference: IP202417-100
EMDN: W0105050105
EMDN description: TOXOPLASMA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:59

Manufacturer products View details

RevoDx Toxoplasma gondii qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213783
Basic UDI-DI: B-08684387213783
Reference: IP202417-25
EMDN: W0105050105
EMDN description: TOXOPLASMA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:59

Manufacturer products View details

RevoDx Cryptosporidium spp qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213165
Basic UDI-DI: B-08684387213165
Reference: IP202439-100
EMDN: W0105050307
EMDN description: CRYPTOSPORIDIUM - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:56

Manufacturer products View details

RevoDx Cryptosporidium spp qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387213158
Basic UDI-DI: B-08684387213158
Reference: IP202439-25
EMDN: W0105050307
EMDN description: CRYPTOSPORIDIUM - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:56

Manufacturer products View details