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61 device results listed.

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Fully automatic library preparation system

iLab-100B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AMTK Inc.
Manufacturer SRN: CN-MF-000046792
UDI-DI: 06978331210020
Basic UDI-DI: 697833121iLab-100BBH
Reference: iLab-100B
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Fully automatic library preparation system

iLab-100A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AMTK Inc.
Manufacturer SRN: CN-MF-000046792
UDI-DI: 06978331210013
Basic UDI-DI: 697833121iLab-100ABF
Reference: iLab-100A
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Fully automatic library preparation system

iLab-100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AMTK Inc.
Manufacturer SRN: CN-MF-000046792
UDI-DI: 06978331210006
Basic UDI-DI: 697833121iLab-100U6
Reference: iLab-100
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

FlashDetect

FM-1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174101
Basic UDI-DI: 697773917080200033E
Reference: 08020003
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Sweden
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Library Preparation System

AISPre 3200, 1600, 3200P

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185135
Basic UDI-DI: 697560818model05FH
Reference: 5135
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

TGuide S16 Nucleic Acid Extractor

TGuide S16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tiangen Biotech (Beijing) Co., Ltd.
Manufacturer SRN: CN-MF-000026594
UDI-DI: 06975489970028
Basic UDI-DI: 697548997OSES168A
Reference: OSE-S16-AM
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: France
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

RNXtract® Automated Purification System

NAP-T8

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKitProfessional testing

Manufacturer: Shuwen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000034318
UDI-DI: 06975394010024
Basic UDI-DI: 697539401SWP13SA
Reference: SWP13
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

BLX Liquid-based Cytology Test Slide Processor

BCT-630II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tianjin Bai Lixin Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000040961
UDI-DI: 06974986838053
Basic UDI-DI: 697498683InSP630IITG
Reference: In-SP630II
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974986838046

BST-12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tianjin Bai Lixin Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000040961
UDI-DI: 06974986838046
Basic UDI-DI: 697498683InST12F7
Reference: In-ST12
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: JARWIS sp. z o.o.
Last updated: 02.07.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

BLX Liquid-based Cytology Test Slide Processor

BCT-630

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tianjin Bai Lixin Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000040961
UDI-DI: 06974986838039
Basic UDI-DI: 697498683InSP630RK
Reference: In-SP630
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

BLX Liquid-based Cytology Test Slide Processor

BCT-620III

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tianjin Bai Lixin Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000040961
UDI-DI: 06974986838022
Basic UDI-DI: 697498683InSP620IIILC
Reference: In-SP620III
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

BLX Liquid-based Cytology Test Slide Processor

BCT-620II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Tianjin Bai Lixin Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000040961
UDI-DI: 06974986838015
Basic UDI-DI: 697498683InSP620IIT9
Reference: BCT-620II
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Poland
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 17:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150343

Rob 75

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150343
Basic UDI-DI: 697360915034KP
Reference: （01）6973609150343（11）210110（21）5382021001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Sweden
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150329

SPS 1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150329
Basic UDI-DI: 697360915032KK
Reference: （01）6973609150329（11）210830（21）5B52021001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Sweden
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973609150114

ASP 150

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Yantai Addcare Bio-Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000018409
UDI-DI: 06973609150114
Basic UDI-DI: 697360915011KB
Reference: （01）6973609150114（11）210830（21）5112021001
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Romania
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Chroma ATE

MagXtract 3200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: CHROMA ATE INC.
Manufacturer SRN: TW-MF-000019529
UDI-DI: 04719889100010
Basic UDI-DI: 471988910MX3G
Reference: MagXtract 3200
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Manta

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: CAMBRIAN BIOTECH PRIVATE LIMITED
Manufacturer SRN: IN-MF-000046319
UDI-DI: 18906193751004
Basic UDI-DI: 890619375CBWM100-CAL
Reference: CBWM100-C
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: -
Authorised representative: Specculo Limited
Last updated: 22.06.2026 12:04

Manufacturer products Authorised representative products Authorised representative actors View details

EntericBio Workstation

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Serosep Limited
Manufacturer SRN: IE-MF-000020322
UDI-DI: 05391513879630
Basic UDI-DI: 0539151387INST2R
Reference: 5070000450
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 20.06.2026 05:34

Manufacturer products View details

Automated Library Preparation System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185173
Basic UDI-DI: 697560818model05FH
Reference: 5173
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Library Preparation System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185180
Basic UDI-DI: 697560818model05FH
Reference: 5180
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 16.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details