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Allplex™ Vaginitis Screening Assay

Allplex™ Vaginitis screening Assay

IVD generalIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101186
Basic UDI-DI: B-08809240101186
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: 24.09.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis Screening Assay

IVD generalNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101575
Basic UDI-DI: B-08809240101575
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: 24.09.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ Vaginitis Screening Assay

IVD generalNot specifiedOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103210
Basic UDI-DI: B-08809240103210
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: 24.09.2026 21:37

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ RV Master Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102084
Basic UDI-DI: 924010RV10307PC
Reference: RV10363Z
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:37

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: 24.09.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Virus Assay

IVD generalIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101674
Basic UDI-DI: B-08809240101674
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: 24.09.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV28 Detection

IVD generalIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103722
Basic UDI-DI: B-08809240103722
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: 24.09.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ HPV28 Detection

IVD generalNot specifiedOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240103739
Basic UDI-DI: B-08809240103739
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: 24.09.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ PneumoBacter Assay

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101766
Basic UDI-DI: B-08809240101766
Reference: PB10176X
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ PneumoBacter Assay

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101759
Basic UDI-DI: B-08809240101759
Reference: PB10175Y
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ PneumoBacter Assay

IVD Annex II List BIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101858
Basic UDI-DI: B-08809240101858
Reference: PB10185Z
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Parasite Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100950
Basic UDI-DI: B-08809240100950
Reference: GI9703X
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Parasite Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100943
Basic UDI-DI: B-08809240100943
Reference: GI9703Y
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Parasite Assay

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102022
Basic UDI-DI: B-08809240102022
Reference: GI10202Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors View details

NG PRECISION +

NG Precision+

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077402038
Basic UDI-DI: 37010774PRECISIONPL_OTCU8
Reference: NGB-HCG-W21-017
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 24.09.2026 21:21

Manufacturer products View details

Test de Grossesse Sanguin

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077401857
Basic UDI-DI: 37010774PRECISIONPL_OTCU8
Reference: NGB-HCG-W21-013
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: -
Last updated: 24.09.2026 21:21

Manufacturer products View details

8681957090034DQ

BRCA1 ve BRCA2 Mutasyonlarını Saptama Kiti

IVD Class CIVDDNo longer on the marketKitReagentSingle use

Manufacturer: MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000050129
UDI-DI: 8681957090034DQ
Basic UDI-DI: 8681957090MLTGNNZ
Reference: M-BR-01
EMDN: W01060203
EMDN description: BRCA 1+2
First on market country: Türkiye
Authorised representative: -
Last updated: 24.09.2026 21:20

Manufacturer products View details

NG PRECISION +

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitSelf testingSingle use

Manufacturer: NG Biotech SAS
Manufacturer SRN: FR-MF-000016216
UDI-DI: 03701077402052
Basic UDI-DI: 37010774PRECISIONPL_OTCU8
Reference: NGB-HCG-W21-018
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: -
Last updated: 24.09.2026 21:20

Manufacturer products View details

Wash Buffer I

1L/Bottle×6

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

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070763220
Basic UDI-DI: 697507076000310RN
Reference: 10201002
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 24.09.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Substrate

130mL×4

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

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070763213
Basic UDI-DI: 697507076000309S5
Reference: 10101002
EMDN: W01010299
EMDN description: SUBSTRATES - OTHER
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 24.09.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details