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707 device results listed.

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A4120

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrument

Manufacturer: Cirdan Imaging Ltd
Manufacturer SRN: XI-MF-000018019
UDI-DI: 50605088200622
Basic UDI-DI: 506050882A4120PA
Reference: A4120
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 22.09.2026 06:55

Manufacturer products View details

Automated Sequencing Library Preparation System MGIFLP-L

MGIFLP-L, GenSIRO-16

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318131234
Basic UDI-DI: 697431813MGIFLPN2
Reference: 900-000636-00; 900-000875-00; 900-000873-00
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.09.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

06956013975207

AVE-752, AVE-752A, AVE-752B, AVE-753, AVE-753A, AVE-753B, AVE-754, AVE-754A, AVE-754B, AVE-755, AVE-755A, AVE-755B, AVE-756, AVE-756A, AVE-756B, AVE-757, AVE-757A, AVE-757B.

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: AVE Science & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000031214
UDI-DI: 06956013975207
Basic UDI-DI: 69560139AUAnalyzerWD
Reference: /
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

06956013966106

AVE-661, AVE-661A, AVE-661B.

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: AVE Science & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000031214
UDI-DI: 06956013966106
Basic UDI-DI: 69560139MAMAnalyzerM2
Reference: /
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Sequencing Library Preparation System GenSIRO-48

MGIFLP-L, GenSIRO-16

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318133481
Basic UDI-DI: 697431813MGIFLPN2
Reference: 900-001093-00
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

High-throughput Automated Sample Preparation System MGISP-960

MGISP-960, MGISP-960B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130428
Basic UDI-DI: 697431813MGISP-960MY
Reference: 900-000157-00, 900-000158-00, 900-000161-00, 900-000162-00, 900-000163-00, 900-000164-00, 900-000165-00, 900-000166-00
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

DNA Sequencing Library Preparation System MGISP-100

MGISP-100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318130411
Basic UDI-DI: 697431813MGISP-100L6
Reference: 900-000207-00, 900-001056-00
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

ThermoBrite Slide Denaturation/ Hybridization System, S500-24

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002109
Basic UDI-DI: 849832026UX
Reference: 3800-004852-004
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

ThermoBrite Slide Denaturation/ Hybridization System, 120V

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002093
Basic UDI-DI: 849832026UX
Reference: 3800-004852-003
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Thermobrite

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002079
Basic UDI-DI: 849832026UX
Reference: 3800-004852-001
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

ThermoBrite Slide Denaturation/ Hybridization System, S500-24

Thermobrite

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Leica Biosystems Richmond, Inc
Manufacturer SRN: US-MF-000014614
UDI-DI: 00849832002086
Basic UDI-DI: 849832026UX
Reference: 3800-004852-002
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 07.08.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

16974969799989

Fluorescent Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Chongqing iSIA BIO-Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003364
UDI-DI: 16974969799989
Basic UDI-DI: 69749697905005ET
Reference: 05
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Czechia
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 12:12

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Hard Tissue Cutting System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Naturn Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000042263
UDI-DI: 06977568270173
Basic UDI-DI: 697756827005RB
Reference: JG9150;JG9250
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Cassette Laser Printer

TB286

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030391
Basic UDI-DI: 697013603039EG
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Slide Laser Printer

G363UV

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030087
Basic UDI-DI: 697013603008E5
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Cassette Ultraviolet Printer

TB586UV

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030056
Basic UDI-DI: 697013603005DX
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Cassette Thermal Printer

TB406I

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030803
Basic UDI-DI: 697013603080ED
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue Cassette Laser Printer

TB406U

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030797
Basic UDI-DI: 697013603079EU
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

Slide Laser Printer

G264D

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030780
Basic UDI-DI: 697013603078ES
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details

Slide Laser Printer

G264P

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangzhou Labsim Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000002446
UDI-DI: 06970136030773
Basic UDI-DI: 697013603077EQ
Reference: REF-TEST
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 08:23

Manufacturer products Authorised representative products Authorised representative actors View details