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D-697603130AFCRC01CZYA

AFCRC01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130AFCRC01CZYA
Basic UDI-DI: B-697603130AFCRC01CZYA
Reference: AFCRC01-AHG4E
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130A0211EYRJ3C

101A0211EY，101A0211ED

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130A0211EYRJ3C
Basic UDI-DI: B-697603130A0211EYRJ3C
Reference: 101A0211EY，101A0211ED
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

FLU-S21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-697177120084296
Basic UDI-DI: B-697177120084296
Reference: FLU-S21（25PCS）
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960AMPV01UYBQ

AMPV01-AOG48E; AMPV01-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960AMPV01UYBQ
Basic UDI-DI: B-69509960AMPV01UYBQ
Reference: AMPV01-AOG48E; AMPV01-AOG96E
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960ADV01QJRZ

ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ADV01QJRZ
Basic UDI-DI: B-69509960ADV01QJRZ
Reference: ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E
EMDN: W0105040511
EMDN description: DENGUE VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

CoviDetect

RT-qPCR Assay

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915CD002LC9H
Basic UDI-DI: B-5713915CD002LC9H
Reference: 8016; 8018; 8022
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

CoviDetect

SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: D-5713915CD001LA98
Basic UDI-DI: B-5713915CD001LA98
Reference: 8015, 8010, 8079
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:48

Manufacturer products View details

CoviDetect

PCR kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: PentaBase A/S
Manufacturer SRN: DK-MF-000023157
UDI-DI: 5713915CD003LE9S
Basic UDI-DI: B-5713915CD003LE9S
Reference: 8213, 8214
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Denmark
Authorised representative: -
Last updated: 17.07.2026 02:40

Manufacturer products View details

Truenat H1N1

601070050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989408
Basic UDI-DI: B-08908007989408
Reference: 601070050
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 17.07.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Norovirus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid AB
Manufacturer SRN: SE-MF-000002020
UDI-DI: 07332940000981
Basic UDI-DI: B-07332940000981
Reference: GXNOV-CE-10
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 16.07.2026 19:55

Manufacturer products View details

+ENTIPRSV61640_

RSV A, RSV B