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197 device results listed.

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GenePure 96 Nucleic Acid Purification System

NPA-96, NPA-96T, NPA-96E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220598
Basic UDI-DI: 697384322NPA003K4
Reference: NPA-96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:04

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Virus /Influenza B Virus Nucleic Acid Detection Kit (Fluorescence RT-PCR)

BSJ04S1, BSJ04M1, BSJ04L1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227917
Basic UDI-DI: 697384322BSJ04JG
Reference: BSJ04L1
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Greece
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus Type A / Type B Nucleic Acid Detection Kit (Fluorescent RT- PCR)

BSJ05S1, BSJ05M1, BSJ05L1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227818
Basic UDI-DI: 697384322BSJ05JJ
Reference: BSJ05L1
EMDN: W0105040505
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma Pneumoniae Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ09S1, BSJ09M1, BSJ09L1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227801
Basic UDI-DI: 697384322BSJ09JS
Reference: BSJ09L1
EMDN: W010501080301
EMDN description: MYCOPLASMA PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Greece
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

MagaBio plus Virus RNA Purification Kit Ⅱ

BSC87T1S, BSC87S1S, BSC87M1S, BSC87N1E, BSC87T1E, BSC87S1E, BSC87M1E, BSC87L1E, BSC87S1B, BSC87M1B, BSC87M1E-T, BSC87L1E-T, BSC87T1P, BSC87S1P

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227610
Basic UDI-DI: 697384322BSC87JB
Reference: BSC87L1E-T
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Preservative Fluid

BSC82S1, BSC82M1, BSC82L1, BSC82N1, BSC82X1-A, BSC82X1-B, BSC82N1-1, BSC82X1-A1, BSC82X1-B1, BSC82X1-C1, BSC82X1-E1, BSC82N1-2, BSC82X1-A2, BSC82X1-B2, BSC82X1-C2, BSC82X1-E2

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843226569
Basic UDI-DI: 697384322BSC82HZ
Reference: BSC82X1-E2
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Transport Medium

BSC93X1-B3

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843226408
Basic UDI-DI: 697384322BSC93J6
Reference: BSC93X1-B3
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Simply P Virus DNA/RNA Extraction Kit

BSC67S1, BSC67M1, BSC67L1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227290
Basic UDI-DI: 697384322BSC67J5
Reference: BSC67L1
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Biospin Omni Genomic DNA Extraction Kit

BSC39S1, BSC39M1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227276
Basic UDI-DI: 697384322BSC39HY
Reference: BSC39M1
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:02

Manufacturer products Authorised representative products Authorised representative actors View details

Biospin Virus DNA/RNA Extraction Kit

BSC77S1, BSC77M1, BSC77L1

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843226248
Basic UDI-DI: 697384322BSC77J8
Reference: BSC77L1
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

MagaBio plus Virus DNA/RNA Purification Kit VI

BSC08S1B, BSC08M1B, BSC08T1P, BSC08S1P, BSC08T1S, BSC08S1S, BSC08M1S, BSC08L1S, BSC08T1E, BSC08S1E, BSC08M1E, BSC08L1E, BSC08T1C, BSC08S1C, BSC08M1E-T, BSC08L1E-T, BSC08T1C-C, BSC08S1C-C, BSC08N1E

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843223742
Basic UDI-DI: 697384322BSC08HM
Reference: BSC08N1E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

MagaBio plus Virus DNA/RNA Purification Kit VI

BSC110S1B, BSC110M1B, BSC110T1S, BSC110S1S, BSC110M1S, BSC110N1E, BSC110T1E, BSC110S1E, BSC110M1E, BSC110L1E, BSC110T1P, BSC110S1P, BSC110M1E-T, BSC110L1E-T, BSC110T1C, BSC110S1C, BSC110T1C-C, BSC110S1C-C

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843223735
Basic UDI-DI: 697384322BSC110FR
Reference: BSC110N1E
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

MagaBio plus Whole Blood Total RNA Purification Kit II

BSC133S1B, BSC133M1B, BSC133T1S, BSC133S1S, BSC133T1E, BSC133S1E, BSC133M1S, BSC133N1E, BSC133T1C, BSC133S1P-A, BSC133M1E, BSC133L1E, BSC133S1C, BSC133T1C-C, BSC133M1E-T, BSC133L1E-T, BSC133S1C-C

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843223568
Basic UDI-DI: 697384322BSC133G5
Reference: BSC133M1S
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

MagaBio plus Virus DNA / RNA Purification Kit Ⅱ

BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T

IVD Class AIVDR 2017/746On the marketDirect markingKitReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221977
Basic UDI-DI: 697384322BSC71HU
Reference: BSC71S1E-N
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene K Plus Fluorescent Quantitative Detection System

FQD-48A(EA2), FQD-48A(EA4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221243
Basic UDI-DI: 697384322FQD003GU
Reference: FQD-48A(EA2)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene Mini Fluorescent Quantitative Detection System

FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843221212
Basic UDI-DI: 697384322FQD001GQ
Reference: FQD-16A(EA2R)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene MiniS Fluorescent Quantitative Detection System

FQD-16B(EA2) , FQD-16B(EA4)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220710
Basic UDI-DI: 697384322FQD002GS
Reference: FQD-16B(EA2)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 15:01

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227856
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02S1
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227825
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02S1A
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

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

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227788
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02M1
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details