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D-697419997WR

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: JOYSBIO(Tianjin) Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003953
UDI-DI: D-697419997WR
Basic UDI-DI: B-697419997WR
Reference: joysbio 01
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:01

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SNCE07XHBY

SNCE07-AOG50E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SNCE07XHBY
Basic UDI-DI: B-69509960SNCE07XHBY
Reference: SNCE07-AOG50E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SNCE05XDBE

SNCE05-BOG48E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SNCE05XDBE
Basic UDI-DI: B-69509960SNCE05XDBE
Reference: SNCE05-BOG48E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960SNCE01X59W

SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG96

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960SNCE01X59W
Basic UDI-DI: B-69509960SNCE01X59W
Reference: SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG96
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

JDBIOTECH

JTBAG

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jei Daniel (JD) Biotech Corp.
Manufacturer SRN: CN-MF-000039637
UDI-DI: D-69301021JTBAGG3E5
Basic UDI-DI: B-69301021JTBAGG3E5
Reference: JTBAG
EMDN: W0105900299
EMDN description: INFECTIOUS IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Total Nucleic Acid Extraction Kit (500ul)

TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)

IVD generalIVDDOn the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: D-5061021472257PJ
Basic UDI-DI: B-5061021472257PJ
Reference: 3B213
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® BS DNA Extraction Kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: D-5061021472240NZ
Basic UDI-DI: B-5061021472240NZ
Reference: 3B215
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Magbead Viral RNA Extraction Kit