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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Last updated

17.07.2026 17:39

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Device

2837824

Actor

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3109

Active filter:Manufacturer SRN:CN-MF-000019512

197 device results listed.

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CentriDxTM Sexually Transmitted Disease Panel I

BSJ69S1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843229416
Basic UDI-DI
B-06973843229416
Reference
BSJ69S1
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
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CentriDxTM Respiratory Pathogen Panel V

BSJ84S1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843229300
Basic UDI-DI
B-06973843229300
Reference
BSJ84S1
EMDN
W0105070503
EMDN description
RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CentriDxTM Gastrointestinal Pathogen Panel Ⅰ

BSJ87S1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843229256
Basic UDI-DI
B-06973843229256
Reference
BSJ87S1
EMDN
W0105070504
EMDN description
GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CentriDxTM Meningitis/Encephalitis Pathogen Panel Ⅰ

BSJ97S1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843229232
Basic UDI-DI
B-06973843229232
Reference
BSJ97S1
EMDN
W0105070505
EMDN description
MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CentriDxTM Lower Respiratory Pathogen Panel Ⅰ

BSJ62S1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221960
Basic UDI-DI
B-06973843221960
Reference
BSJ62S1
EMDN
W0105070503
EMDN description
RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
CentriDxTM Tropical Fever Pathogen Panel Ⅰ

BSJ96S1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221953
Basic UDI-DI
B-06973843221953
Reference
BSJ96S1
EMDN
W0105070506
EMDN description
TROPICAL FEVER - MULTIPLEX NA REAGENTS
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 17:40
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AutoGene 9600 Automatic PCR Analysis System

FQD-A9600(EA4), FQD-A9600(EA5), FQD-A9600(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221342
Basic UDI-DI
697384322FQD010GR
Reference
FQD-A9600(EA4)
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 productsAuthorised representative productsAuthorised representative actorsView details
LineGene 9600 Pro Fluorescenct Quantitative Detection System

FQD-96A(ED2), FQD-96A(ED4), FQD-96A(ED5), FQD-96A(ED6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221304
Basic UDI-DI
697384322FQD009H8
Reference
FQD-96A(ED2)
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 productsAuthorised representative productsAuthorised representative actorsView details
careSTART™ Q1 Amplifier

TQA-E00182

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221298
Basic UDI-DI
697384322FQD008H6
Reference
TQA-E00182
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 productsAuthorised representative productsAuthorised representative actorsView details
GenePure Pro 16H Nucleic Acid Purification System

NPA-16H

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221274
Basic UDI-DI
697384322NPA001JY
Reference
NPA-16H
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 productsAuthorised representative productsAuthorised representative actorsView details
VitroCycler Fluorescent Quantitative Detection System

VIT-VitroCycler

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221267
Basic UDI-DI
697384322FQD007H4
Reference
VIT-VitroCycler
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 productsAuthorised representative productsAuthorised representative actorsView details
GenePure Pro 9600 Nucleic Acid Purification System

NPAm-9600

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221205
Basic UDI-DI
697384322NPA005K8
Reference
NPAm-9600
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 productsAuthorised representative productsAuthorised representative actorsView details
CentriDx Automated Nucleic Acid Analyzer

CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221175
Basic UDI-DI
697384322FQD012GV
Reference
CentriDx 200(EA4)
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 productsAuthorised representative productsAuthorised representative actorsView details
Bioquant-96m Fluorescent Quantitative Detection System

Bioquant-96m

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843221168
Basic UDI-DI
697384322FQD011GT
Reference
Bioquant-96m
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 productsAuthorised representative productsAuthorised representative actorsView details
LineGene 9600 Plus Fluorescent Quantitative Detection System

FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843220765
Basic UDI-DI
697384322FQD004GW
Reference
FQD-96A(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 15:04
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
GeneExplorer Thermal Cycler

GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843220734
Basic UDI-DI
697384322TC001H3
Reference
GE-96G
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 productsAuthorised representative productsAuthorised representative actorsView details
Automated Nucleic Acid Purification and Real Time PCR System

FQD-A1600(EA4), FQD-A1600(EA5), FQD-A1600(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843220680
Basic UDI-DI
697384322FQD006H2
Reference
FQD-A1600(EA4)
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 productsAuthorised representative productsAuthorised representative actorsView details
Automated Nucleic Acid Purification System

NPAs-9600,NPAs-9620

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843220673
Basic UDI-DI
697384322NPA004K6
Reference
NPAs-9600
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 productsAuthorised representative productsAuthorised representative actorsView details
GenePure Pro Nucleic Acid Purification System

NPA-32P, NPA-32E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843220659
Basic UDI-DI
697384322NPA002K2
Reference
NPA-32P
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 productsAuthorised representative productsAuthorised representative actorsView details
QuantGene 9600 Fluorescent Quantitative Detection System

FQD-96C(EA4), FQD-96C(EA5), FQD-96C(EA6)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing
Manufacturer
Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN
CN-MF-000019512
UDI-DI
06973843220628
Basic UDI-DI
697384322FQD005GY
Reference
FQD-96C(EA4)
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 productsAuthorised representative productsAuthorised representative actorsView details