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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

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

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

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

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

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

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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

PREP-NA DNA/RNA Extraction Kit

PREP-NA DNA/RNA Extraction Kits

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014364749
Basic UDI-DI: 466001436RA041WY
Reference: P-034-N/1EU
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

PREP-MB DWP DNA/RNA Extraction Kit, Package A

PREP-MB DWP DNA/RNA 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: 04660014362974
Basic UDI-DI: 466001436RA072XB
Reference: Р-119-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

PREP-OPTIMA DNA Extraction Kit. Package S

PREP-OPTIMA 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: 04660014363070
Basic UDI-DI: 466001436RA060X4
Reference: P-016-1/2EU
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

04660014362325

PREP-NA-S DNA/RNA Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362325
Basic UDI-DI: 466001436RA047XC
Reference: P-007-N/1EU
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

PREP-GS PLUS DNA Extraction Kit

PREP-GS DNA Extraction Kits

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014362226
Basic UDI-DI: 466001436RA046XA
Reference: P-003/2EU
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

Extraction purification kit of NA for blood 96R IVD

Extraction and purification kit of NA for blood

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: AD Nucleis
Manufacturer SRN: FR-MF-000002215
UDI-DI: 37604277000264
Basic UDI-DI: 376042770112B4
Reference: Kit-EP_96_112_I_PF
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: 16.07.2026 08:06

Manufacturer products View details

HighPrep Viral DNA & RNA Kit - DX (3840 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030995
Basic UDI-DI: 0850045030HPV-DR3840ERV
Reference: HPV-DR3840E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep Viral DNA & RNA Kit - DX (20 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030346
Basic UDI-DI: 0850045030HPV-DR20EMK
Reference: HPV-DR20E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep Viral DNA & RNA Kit - DX (384 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030070
Basic UDI-DI: 0850045030HPV-DR96x4E5N
Reference: HPV-DR96x4E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

HighPrep Viral DNA & RNA Kit - DX (96 preps)

Kit for viral RNA and DNA isolation

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MagBio Genomics, Inc.
Manufacturer SRN: US-MF-000038221
UDI-DI: 00850045030063
Basic UDI-DI: 0850045030HPV-DR96EP8
Reference: HPV-DR96E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

Quick-RNA Viral 96 Kit - DX (2 x 96 preps)

R2140-E

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zymo Research Corp.
Manufacturer SRN: US-MF-000019308
UDI-DI: 00850027600208
Basic UDI-DI: 0850027600R2140FM
Reference: R1040-E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: France
Authorised representative: DAVID Catherine Elisabeth Marie
Last updated: 16.07.2026 06:21

Manufacturer products Authorised representative products Authorised representative actors View details