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06974795551020

Archimed X6

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551020
Basic UDI-DI: 6974795551002CAC
Reference: Archimed X6
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551013

Archimed X4

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551013
Basic UDI-DI: 6974795551001CA9
Reference: Archimed X4
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

06974737220205

Automatic Nucleic Acid Detection and Analysis System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220205
Basic UDI-DI: 697473722AutoSAT47
Reference: AutoSAT
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

C10 easyPCR System

C10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626018
Basic UDI-DI: 697468962601S7
Reference: N/A
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974689625219

D20

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625219
Basic UDI-DI: 697468962521S8
Reference: NA
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

D30 Automatic Digital PCR System

D30

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625189
Basic UDI-DI: 697468962518SK
Reference: 30175
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

D50 Automatic Digital PCR System

D50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625172
Basic UDI-DI: 697468962517SH
Reference: 30171
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Chip Reader

Chip Reader R1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625103
Basic UDI-DI: 697468962510S3
Reference: 30052
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Drop Maker

Drop Maker M1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625097
Basic UDI-DI: 697468962509SJ
Reference: 30002
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Chip Reader

Chip Reader R2

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625080
Basic UDI-DI: 697468962508SG
Reference: 30154
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

BNP027-5E

IVD Class AIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 16974660730625
Basic UDI-DI: 697466073P02RZ
Reference: BNP027-5E 48pcs/box
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:10

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-N96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730154
Basic UDI-DI: 697466073NAESN96P04G2
Reference: NAES-N96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-96Plus

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730147
Basic UDI-DI: 697466073NAES96PP04CC
Reference: NAES-96Plus
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-96

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730130
Basic UDI-DI: 697466073NAES96P04MJ
Reference: W
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-48

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730123
Basic UDI-DI: 697466073NAES48P04L9
Reference: NAES-48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Biocomma

NAES-32

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testingSingle use

Manufacturer: Biocomma Limited
Manufacturer SRN: CN-MF-000013631
UDI-DI: 06974660730116
Basic UDI-DI: 697466073NAES32P04JL
Reference: NAES-32
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:06

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extracting System

AiNP 96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212439
Basic UDI-DI: 697462121AiNPNW
Reference: AiNP 96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extracting System

AiNA32

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Aikang MedTech Co., Ltd
Manufacturer SRN: CN-MF-000027272
UDI-DI: 06974621212422
Basic UDI-DI: 697462121AiNAMY
Reference: AiNA32
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:04

Manufacturer products Authorised representative products Authorised representative actors View details

06974613760160

QG28800

IVD Class AIVDR 2017/746On the marketHuman tissuesInstrumentKitProfessional testing

Manufacturer: Shanghai ZJ Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000023075
UDI-DI: 06974613760160
Basic UDI-DI: 697461376020004TE
Reference: ZJYY-D-20220E
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:02

Manufacturer products Authorised representative products Authorised representative actors View details

06974591041145

H24

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041145
Basic UDI-DI: 6974591041006B2
Reference: H24
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details