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282 device results listed.

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CLO for cobas 8100

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943845
Basic UDI-DI: 761333602163AG
Reference: 07439997001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

BCL for cobas 8100

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943791
Basic UDI-DI: 761333602160AA
Reference: 07123922001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

AOB for cobas 8100

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943777
Basic UDI-DI: 761333602158AP
Reference: 07123914001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

OBS for cobas 8100

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943760
Basic UDI-DI: 761333602170AD
Reference: 07123892001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

RSF for cobas 8100

cobas 8100 automated workflow series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hitachi High-Tech Corporation
Manufacturer SRN: JP-MF-000016991
UDI-DI: 04015630943753
Basic UDI-DI: 761333602174AM
Reference: 07123876001
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Roche Diagnostics GmbH
Last updated: 03.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

06978704660001

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704660001
Basic UDI-DI: 697870466P45K
Reference: 290540
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:55

Manufacturer products Authorised representative products Authorised representative actors View details

06978556700009

Bactready

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Tianjin Readybio Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000047939
UDI-DI: 06978556700009
Basic UDI-DI: 697855670A001KD
Reference: Bactready
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor

NAE Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780302
Basic UDI-DI: 697850778NAE10QF
Reference: IN0104
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

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

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

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

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

Nanomation™ G1 Pro

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Nanomics Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000037129
UDI-DI: 06976678590010
Basic UDI-DI: 697667859G10WE
Reference: G10
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 21:53

Manufacturer products Authorised representative products Authorised representative actors View details

06976301910413

Bio-filler

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Yingtai Instrument Co., Ltd
Manufacturer SRN: CN-MF-000034851
UDI-DI: 06976301910413
Basic UDI-DI: 697630191Bio-filler5G
Reference: I010
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06976301910406

PRP-Gel

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Yingtai Instrument Co., Ltd
Manufacturer SRN: CN-MF-000034851
UDI-DI: 06976301910406
Basic UDI-DI: 697630191PRP-Gel4C
Reference: I009
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06976301910390

PRP-filler

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Yingtai Instrument Co., Ltd
Manufacturer SRN: CN-MF-000034851
UDI-DI: 06976301910390
Basic UDI-DI: 697630191PRP-fillerMP
Reference: I008
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06976301910383

PPP-filler

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Yingtai Instrument Co., Ltd
Manufacturer SRN: CN-MF-000034851
UDI-DI: 06976301910383
Basic UDI-DI: 697630191PPP-fillerL9
Reference: I007
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06976301910376

IBio-filler

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Changsha Yingtai Instrument Co., Ltd
Manufacturer SRN: CN-MF-000034851
UDI-DI: 06976301910376
Basic UDI-DI: 697630191IBio-fillerXL
Reference: I006
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details