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RADIONE 4ch

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204301888
Basic UDI-DI: 880002043POCF8
Reference: KM010
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Molecule Workstation

S-Q31B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731318
Basic UDI-DI: 69557927SQ31B0000001J5
Reference: S-Q31B
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 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Molecule Workstation

S-Q31A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731301
Basic UDI-DI: 69557927SQ31A0000001HJ
Reference: S-Q31A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Molecular Workstation

S-Q36A, S-Q36B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730496
Basic UDI-DI: 69557927SQ3600000001BM
Reference: S-Q36B
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 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Analysis Device

S-Q35C

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730489
Basic UDI-DI: 69557927SQ35C0000001ML
Reference: S-Q35C
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 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Molecular Workstation

S-Q36A, S-Q36B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730472
Basic UDI-DI: 69557927SQ3600000001BM
Reference: S-Q36A
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 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated Nucleic Acid Extraction System

S-S13A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792712966
Basic UDI-DI: 69557927SS13A0000001K4
Reference: S-S13A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors View details

06955792701731

S-S13E-P; S-S13E-P1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701731
Basic UDI-DI: 69557927SS13EP00000162
Reference: S-S13E-P1
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 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

06955792701724

S-S13E-P; S-S13E-P1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701724
Basic UDI-DI: 69557927SS13EP00000162
Reference: S-S13E-P
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 20:21

Manufacturer products Authorised representative products Authorised representative actors View details

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

Real-Time PCR System

FZ-960

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110996117
Basic UDI-DI: 69511109FZ-960DC
Reference: FZ-960
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-80

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110980253
Basic UDI-DI: 69511109FZ-80GD
Reference: FZ-80
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-3840

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110938414
Basic UDI-DI: 69511109FZ-38408L
Reference: FZ-3840
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System

FZ-100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Everbest Machinery lndustry Co., Ltd.
Manufacturer SRN: CN-MF-000008730
UDI-DI: 06951110910274
Basic UDI-DI: 69511109FZ-100BJ
Reference: FZ-100
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 09:37

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