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RevoDx SARS-CoV-2 qPCR Kit v2.2

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717189
Basic UDI-DI: B-08683079717189
Reference: IP202008-100
EMDN: W0105041106
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Austria
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx Viral Nucleic Acid Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717011
Basic UDI-DI: B-08683079717011
Reference: IP201906 -100
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

RevoDx Viral Nucleic Acid Purification Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08683079717004
Basic UDI-DI: B-08683079717004
Reference: IP201906 -50
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Türkiye
Authorised representative: -
Last updated: 04.08.2026 09:21

Manufacturer products View details

Allplex™ Candidiasis Assay

AllplexA™ Candidiasis Assay

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100738
Basic UDI-DI: 924010SD98030LF
Reference: SD9803X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101186
Basic UDI-DI: 924010SD97500LQ
Reference: SD9750X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101575
Basic UDI-DI: 924010SD97500LQ
Reference: SD9750Y
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Bacterial Vaginosis plus Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101599
Basic UDI-DI: 924010SD10159GU
Reference: SD10159X
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Virus Assay

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101674
Basic UDI-DI: 924010GI97010FP
Reference: GI10184Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Virus Assay

IVD generalNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101681
Basic UDI-DI: B-08809240101681
Reference: GI9701X
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:38

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Candidiasis Assay

IVD Class BNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101780
Basic UDI-DI: 924010SD98030LF
Reference: SD10178Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Bacterial Vaginosis plus Assay

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103203
Basic UDI-DI: 924010SD10159GU
Reference: SD10320Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis screening Assay

IVD Class CNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103210
Basic UDI-DI: 924010SD97500LQ
Reference: SD10321Z
EMDN: W0105070502
EMDN description: OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV28 Detection

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103722
Basic UDI-DI: 924010HP10372FX
Reference: HP10372X
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV28 Detection

IVD Class CNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103739
Basic UDI-DI: 924010HP10372FX
Reference: HP10373Z
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 08:28

Manufacturer products Authorised representative products Authorised representative actors View details

FR799

FR799-Identification of human specific ß-Actin

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430010
Basic UDI-DI: 426242043GEN222SR
Reference: FR799
EMDN: W0105080908
EMDN description: STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT
First on market country: Germany
Authorised representative: -
Last updated: 04.08.2026 06:29

Manufacturer products View details

GeneProof BK Virus (BKV) PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302047
Basic UDI-DI: B-08595696302047
Reference: BKV/GP/100
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 04:30

Manufacturer products View details

GeneProof BK Virus (BKV) PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302023
Basic UDI-DI: B-08595696302023
Reference: BKV/GP/025
EMDN: W0105040522
EMDN description: BK VIRUS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 04:30

Manufacturer products View details

GeneProof Trichomonas vaginalis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161957867
Basic UDI-DI: B-08594161957867
Reference: TV/GP/100
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 04:29

Manufacturer products View details

GeneProof Trichomonas vaginalis PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161957843
Basic UDI-DI: B-08594161957843
Reference: TV/GP/025
EMDN: W0105050310
EMDN description: TRICHOMONAS - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 04:29

Manufacturer products View details

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08594161951575
Basic UDI-DI: B-08594161951575
Reference: HSV/ISEX/100
EMDN: W0105040311
EMDN description: HSV - NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 04.08.2026 04:29

Manufacturer products View details