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TRUPCR® Magbead FFPE Tissue DNA Extraction Kit

TRUPCR® Magbead FFPE Tissue DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931174
Basic UDI-DI: 8906213933B335YS
Reference: 3B335
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 Blood DNA Extraction Kit

TRUPCR® Magbead Blood DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931143
Basic UDI-DI: 8906213933B333YN
Reference: 3B333
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® Panel Extraction Kit

TRUPCR® Panel Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931129
Basic UDI-DI: 8906213933B1401EQU
Reference: 3B1401E
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® Tissue DNA Extraction Kit

TRUPCR® Tissue DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931105
Basic UDI-DI: 8906213933B207YG
Reference: 3B207
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® BS DNA Extraction Kit

TRUPCR® BS DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931068
Basic UDI-DI: 8906213933B215YF
Reference: 3B215
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® FFPE Tissue DNA Extraction Kit

TRUPCR® FFPE Tissue DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931082
Basic UDI-DI: 8906213933B207FTX
Reference: 3B207F
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® Blood RNA Extraction Kit

TRUPCR® Blood RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931044
Basic UDI-DI: 8906213933B1200S3
Reference: 3B1200
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® Blood DNA Extraction Kit

TRUPCR® Blood DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213931013
Basic UDI-DI: 8906213933B205YC
Reference: 3B205
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® Total Viral Nucleic Acid Extraction Kit

TRUPCR® 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: 08906213930948
Basic UDI-DI: 8906213933B213YB
Reference: 3B214
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® Total Nucleic Acid Extraction Kit

TRUPCR® 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: 08906213930887
Basic UDI-DI: 8906213933B347YZ
Reference: 3B347
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® Total Nucleic Acid Extraction Kit

TRUPCR® 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: 08906213930856
Basic UDI-DI: 8906213933B216YH
Reference: 3B216
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® Viral RNA Extraction Kit

TRUPCR® Viral RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930962
Basic UDI-DI: 8906213933B214VUT
Reference: 3B214V
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® MTB/NTM DNA Extraction Kit

TRUPCR® 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: 08906213930825
Basic UDI-DI: 8906213933B268EUW
Reference: 3B268E
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® Bacterial/Fungal DNA Extraction Kit

TRUPCR® Bacterial/Fungal DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930795
Basic UDI-DI: 8906213933B345YV
Reference: 3B345
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® Bacterial DNA Extraction Kit

TRUPCR® Bacterial DNA Extraction Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930764
Basic UDI-DI: 8906213933B371YW
Reference: 3B371
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

302012

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019711244
Basic UDI-DI: 888501971302012U8
Reference: 302012
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Pathogen DNA/RNA Purification Kit (Beads)

BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Beiwo Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027312
UDI-DI: 06975573960133
Basic UDI-DI: 697557396bwyx007MM
Reference: BW-MGD2411-A32-32
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Ireland
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors View details

Aptima Assay Fluids

Reagents and Fluids

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

Manufacturer: Hologic
Manufacturer SRN: US-MF-000001646
UDI-DI: 15420045500280
Basic UDI-DI: 54200455DIAGFLUIDSBG
Reference: 303014
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: Hologic BV
Last updated: 16.07.2026 10:02

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® Genomic DNA Whole Blood Kit (Speedy installation)

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 14719890671001
Basic UDI-DI: 471989067M0000A9
Reference: MGB400-02
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

PREP-MB-RAPID II DNA Extraction Kit, Package A

PREP-MB-RAPID II DNA Extraction Kit

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

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014364817
Basic UDI-DI: 466001436RA079XR
Reference: Р-122-A/9EU
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: 16.07.2026 09:30

Manufacturer products Authorised representative products Authorised representative actors View details