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06955792700048

Portable Molecular Diagnostic System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792700048
Basic UDI-DI: 69557927SQ3700000001CC
Reference: S-Q37B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

06955792700000

Portable Molecular Diagnostic System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792700000
Basic UDI-DI: 69557927SQ3700000001CC
Reference: S-Q37A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

06951045800053

Pre-NAT II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045800053
Basic UDI-DI: 69510458INST_PreNATIISRW
Reference: SY61-01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

06951045800046

Pre-NAT II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045800046
Basic UDI-DI: 69510458INST_PreNATIIGR6
Reference: SY61
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Pre-NAT II (SY61-EI)

Automated Workstation

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045800039
Basic UDI-DI: 69510458INST_PreNATII6Z
Reference: SY61-EI
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 28.06.2026 09:35

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300137
Basic UDI-DI: 6936895BS0082G
Reference: BS008
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300144
Basic UDI-DI: 6936895BS0082G
Reference: BS008
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301165
Basic UDI-DI: 6936895BS0082G
Reference: BK-HS32mini
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301172
Basic UDI-DI: 6936895BS0082G
Reference: BK-HS96A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301189
Basic UDI-DI: 6936895BS0082G
Reference: BK-HS96B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301196
Basic UDI-DI: 6936895BS0082G
Reference: BK-HS96C
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301202
Basic UDI-DI: 6936895BS0082G
Reference: BK-HS96D
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301219
Basic UDI-DI: 6936895BS0082G
Reference: BK-HS96E
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 26.06.2026 14:18

Manufacturer products Authorised representative products Authorised representative actors View details

3500xL Dx Genetic Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302005944
Basic UDI-DI: 0190302TCF00005084L
Reference: 4405183 (A27856)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 26.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018876
Basic UDI-DI: 0190302A50534RM
Reference: A50535
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 26.06.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction Instrument

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103080443
Basic UDI-DI: 69281030804XFX
Reference: DA8044
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 26.06.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Extraction Instrument

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103080450
Basic UDI-DI: 69281030804XFX
Reference: DA8045
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 26.06.2026 06:40

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Real-time PCR System

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205203
Basic UDI-DI: 697326286000792G
Reference: 02-17-01-0024-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Real-time PCR System

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205197
Basic UDI-DI: 697326286000792G
Reference: 02-17-01-0023-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Real-time PCR System

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205180
Basic UDI-DI: 697326286000792G
Reference: 02-17-01-0022-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:47

Manufacturer products Authorised representative products Authorised representative actors View details