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IVD Class ANot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711275
Basic UDI-DI: 888501971302013UA
Reference: 302013
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

NUCLISENS® easyMAG® Lysis Buffer

NUCLISENS® easyMAG® Lysis Buffer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026596224
Basic UDI-DI: 357302BUDI000602TC
Reference: 541818
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

NUCLISENS® easyMAG® Magnetic Silica

NUCLISENS® easyMAG® Magnetic Silica

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026596217
Basic UDI-DI: 357302BUDI000507TH
Reference: 541817
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

NUCLISENS® easyMAG® Extraction Buffer 3

NUCLISENS® easyMAG® Extraction Buffer 3

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026596200
Basic UDI-DI: 357302BUDI000506TF
Reference: 541816
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

NUCLISENS® easyMAG® Extraction Buffer 2

NUCLISENS® easyMAG® Extraction Buffer 2

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026596194
Basic UDI-DI: 357302BUDI000505TD
Reference: 541815
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

NUCLISENS® easyMAG® Extraction Buffer 1

NUCLISENS® easyMAG® Extraction Buffer 1

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026596187
Basic UDI-DI: 357302BUDI000504TB
Reference: 541814
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

PREP-MB MAX DNA Extraction Kit, Package N

PREP-MB MAX DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014363049
Basic UDI-DI: 466001436RA070X7
Reference: Р-103-N/4EU
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 17.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130SNCE07H6WE

SNCE07-ADW50E

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130SNCE07H6WE
Basic UDI-DI: B-697603130SNCE07H6WE
Reference: SNCE07-ADW50E
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 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130SNCE05H2VU

SNCE05-ADW48

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130SNCE05H2VU
Basic UDI-DI: B-697603130SNCE05H2VU
Reference: SNCE05-ADW48
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 04:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130SNCE01GSX5

SNCE01-ADW48,SNCE01-ADW96

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130SNCE01GSX5
Basic UDI-DI: B-697603130SNCE01GSX5
Reference: SNCE01-ADW48,SNCE01-ADW96
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 04:18

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

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

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

TRUPCR® Magbead Viral RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931327
Basic UDI-DI: 8906213933B213BTG
Reference: 3B213B
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit

TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931297
Basic UDI-DI: 8906213933B336YU
Reference: 3B336
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Magbead Total Nucleic Acid Extraction Kit

TRUPCR® Magbead Total Nucleic Acid Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931266
Basic UDI-DI: 8906213933B339Z2
Reference: 3B339
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Magbead Tissue DNA Extraction Kit

TRUPCR® Magbead Tissue DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931228
Basic UDI-DI: 8906213933B334YQ
Reference: 3B334
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Magbead MTB/NTM DNA Extraction Kit

TRUPCR® Magbead MTB/NTM DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931204
Basic UDI-DI: 8906213933B337YW
Reference: 3B437
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 16.07.2026 12:53

Manufacturer products Authorised representative products Authorised representative actors View details