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281 device results listed.

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HighPlex System

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044002298
Basic UDI-DI: 93430440W02039006V6
Reference: 91501
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
First on market country: Italy
Authorised representative: R-Biopharm AG
Last updated: 04.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

I-PREP2

I-PREP LBC Processor

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Imedikers Co., Ltd.
Manufacturer SRN: KR-MF-000047937
UDI-DI: 08800317990009
Basic UDI-DI: 880031799IP01DY
Reference: Liquid Based Cytology System I-PREP USER MANUAL Ver.01
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Romania
Authorised representative: Veritas Eston OÜ
Last updated: 03.07.2026 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

PhenoMATRIX

IVD Class CIVDR 2017/746On the market

Manufacturer: Copan Wasp S.r.l.
Manufacturer SRN: IT-MF-000012489
UDI-DI: 58059796360857
Basic UDI-DI: 805014821IP250CMDSWM02ZA
Reference: WLAB-PHENOMATRIX
EMDN: W02039092
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:36

Manufacturer products View details

WASPLab Single Incubator

WASPLab System

IVD Class AIVDR 2017/746No longer on the marketInstrument

Manufacturer: Copan Wasp S.r.l.
Manufacturer SRN: IT-MF-000012489
UDI-DI: 58050148211438
Basic UDI-DI: 805014821IP040AAUTOM01UB
Reference: W087-011
EMDN: W02039099
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:36

Manufacturer products View details

SaCycler-96R Real Time PCR System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sacace Biotechnologies S.r.l
Manufacturer SRN: IT-MF-000031072
UDI-DI: 08050054301228
Basic UDI-DI: 805005430STR019A9P
Reference: SC-96R
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:32

Manufacturer products View details

06979232310031

CP-AS-Ⅱ

IVD Class AIVDR 2017/746On the market

Manufacturer: Shanghai LeChen Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000051606
UDI-DI: 06979232310031
Basic UDI-DI: 697923231003KU
Reference: 06979232310031
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Austria
Authorised representative: Everbiz GmbH
Last updated: 03.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Cycler

PCR Series, PCRTC Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780180
Basic UDI-DI: 697850778PXR10Y7
Reference: IN0108
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
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

CO2 Incubator

ICB Series, EGI Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780142
Basic UDI-DI: 697850778ICB10NP
Reference: 0302
EMDN: W02039002
EMDN description: CARBON DIOXIDE INCUBATORS
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

06978230082308

HE7230

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230082308
Basic UDI-DI: 697823008HE7230A8
Reference: 230
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230081325

HE6130P

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230081325
Basic UDI-DI: 697823008HE6130PBA
Reference: 130P
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230081318

HE6130L

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230081318
Basic UDI-DI: 697823008HE6130LB2
Reference: 130L
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230081301

HE6130

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230081301
Basic UDI-DI: 697823008HE61309U
Reference: 130
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230081103

HE6110

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230081103
Basic UDI-DI: 697823008HE61109N
Reference: 110
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230081080

HE6108

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230081080
Basic UDI-DI: 697823008HE6108A3
Reference: 108
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230080106

HE6010

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230080106
Basic UDI-DI: 697823008HE60109H
Reference: 010
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

06978230080083

HE6008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Beiant Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000045896
UDI-DI: 06978230080083
Basic UDI-DI: 697823008HE60089W
Reference: 008
EMDN: W02039004
EMDN description: AUTOMATED SLIDE PREPARATION UNITS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Colony Picker (DCP)

DCP 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Qingdao Single-Cell Biotech. Co., Ltd.
Manufacturer SRN: CN-MF-000047609
UDI-DI: 06977908840028
Basic UDI-DI: 697790884DCP100005AN
Reference: IVDR
EMDN: W02039099
EMDN description: VARIOUS MICROBIOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Thermal Cycler

WHYA10, WHYA20, WHYA30, Q200A, Q200B, Q200C, G100, WG100, G101, G200, M1601, M1601F, A08, A09

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing Poweam Medical Co., Ltd
Manufacturer SRN: CN-MF-000040207
UDI-DI: 06977226450497
Basic UDI-DI: 697722645BTTC01QD
Reference: WHYA10
EMDN: W02039006
EMDN description: DNA THERMAL CYCLERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:23

Manufacturer products Authorised representative products Authorised representative actors View details

NK Cell Induction and Expansion Culture Kit

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

Manufacturer: REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000037130
UDI-DI: 06976683270020
Basic UDI-DI: 697668327NK78
Reference: Type A
EMDN: W02039005
EMDN description: CULTURE MEDIUM PREPARATION UNITS
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

Mesenchymal Stem Cell Serum-Free Medium

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000037130
UDI-DI: 06976683270006
Basic UDI-DI: 697668327MSCYL
Reference: Type A
EMDN: W02039005
EMDN description: CULTURE MEDIUM PREPARATION UNITS
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