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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

06978319540026

TD2；TD3；TD4；TD5；TD5.5； TD6； TD4A；TD4G；TD4K；TD4N；TD4T；TD4X；TD4Y;TD5A；TD5B;TD5G； TD5M；TD5P；TD5T； TD5X； TD5Z； TD6B； TD6K； D5B；D5M；D5T；etc

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Lu Xiangyi Centrifuge Instrument Co., Ltd
Manufacturer SRN: CN-MF-000042568
UDI-DI: 06978319540026
Basic UDI-DI: 697831954LXYCEN63
Reference: TD4
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:27

Manufacturer products Authorised representative products Authorised representative actors View details

Microtome

KD-2268

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: ZHEJIANG JINHUA KEDI INSTRUMENTAL EQUIPMENT CO.,LTD
Manufacturer SRN: CN-MF-000045525
UDI-DI: 06978114660004
Basic UDI-DI: 697811466microtomeUW
Reference: KD-2268
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 23:17

Manufacturer products Authorised representative products Authorised representative actors View details

06977889900001

CENTRIFUGE

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: CHANGZHOU RICHGENIUS MEDLAB CO.,LTD
Manufacturer SRN: CN-MF-000051661
UDI-DI: 06977889900001
Basic UDI-DI: 697788990RJLSC7P
Reference: 800D
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Türkiye
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 23:06

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 Liquid Handling Workstation

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou MegaRobo Technologies Co.,Ltd
Manufacturer SRN: CN-MF-000044436
UDI-DI: 06977703440034
Basic UDI-DI: 697770344GalatekAuflo8A
Reference: Auflo-J1600
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

MEGAROBO Liquid Handling Workstation

Liquid Handling Workstation

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou MegaRobo Technologies Co.,Ltd
Manufacturer SRN: CN-MF-000044436
UDI-DI: 06977703440010
Basic UDI-DI: 697770344Auflo6H
Reference: Auflo-P1200-S1
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NATPure System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: 06977537461823
Basic UDI-DI: 697753746CW11R5
Reference: CW11022Q
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

Centrifuge 5425 R

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Eppendorf SE
Manufacturer SRN: DE-MF-000006237
UDI-DI: 04043758045448
Basic UDI-DI: 04043758-IA-CEN-003-NW
Reference: 5406000412
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

Centrifuge 5425

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Eppendorf SE
Manufacturer SRN: DE-MF-000006237
UDI-DI: 04043758045479
Basic UDI-DI: 04043758-IA-CEN-009-PG
Reference: 5405000418
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

Centrifuge 5425

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Eppendorf SE
Manufacturer SRN: DE-MF-000006237
UDI-DI: 04043758045530
Basic UDI-DI: 04043758-IA-CEN-009-PG
Reference: 5405000020
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:38

Manufacturer products View details

Centrifuge 5425 R

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Eppendorf SE
Manufacturer SRN: DE-MF-000006237
UDI-DI: 04043758045424
Basic UDI-DI: 04043758-IA-CEN-003-NW
Reference: 5406000014
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: -
Authorised representative: -
Last updated: 02.07.2026 22:37

Manufacturer products View details

Sample Preparation Workstation（PCore）

LS450、PCore

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Chengdu Legend-Tec Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047100
UDI-DI: 06977357002206
Basic UDI-DI: 697735700219MM
Reference: LGSW002
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: GRZAN GROUP SL
Last updated: 02.07.2026 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

06977211620027

DE-MAR、DE-MIR、DE-LIN

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620027
Basic UDI-DI: 697721162HSDCSLD
Reference: DE-MAR
EMDN: W02069085
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

EASY-TLT

SM-200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620010
Basic UDI-DI: 697721162HSLBCSPXN
Reference: SM-200
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

Healtshsky

SCTE-3600A, SCTE-3600AP

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou HealthSky Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000040002
UDI-DI: 06977211620003
Basic UDI-DI: 697721162HSFALBCW98
Reference: SCTE-3600A
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

KUOHAI TECHNOLOGY

KCT-05 KCT-06 KCT-07 KCT-08 KCT-10 KCT-11 KCT-12 KCT-13 KCT-14 KCT-15 KCT-16 KCT-17 KCT-18 KCT-19 KCT-20

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSterile

Manufacturer: Xiaogan Kuohai Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000040038
UDI-DI: 06977185070590
Basic UDI-DI: 697718507KHLBCPTZ
Reference: KCT-05
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

06977168240002

TDL-600A、DL-1000C、TDL-200、TDL-280、TDL-320、TDL-350、TDL-360、TDL-400、TDL-420、 TDL-450、TDL-5000、TDL-360C、TDL-400C、TDL-500C、 TDL-600C、TDL-36B、etc

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shandong Baiou Medical Technology Co., LTD
Manufacturer SRN: CN-MF-000039886
UDI-DI: 06977168240002
Basic UDI-DI: 697716824BOCENTRIFUGEQ7
Reference: TDL-600A
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:14

Manufacturer products Authorised representative products Authorised representative actors View details