Manufacturer

Wuhan MGI Tech

ChinaLegal entities : Wuhan MGI Tech Co., Ltd.

Markets : Latvia

Approvals : EU – class IIa, A

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

8 categories, 19 models including 19 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
IVD instruments - other	W0299	Automated Nucleic Acid Extractor MGISP-NE32 MGISP-NE32, MGISP-NE384, MGISP-NEX3 refs Automated Sample Preparation System MGISP-Smart8 Automated Sequencing Library Preparation System GenSIRO-16 MGIFLP-L, GenSIRO-16, GenSIRO-483 refs DNA Sequencing Library Preparation System MGISP-100 High-throughput Automated Sample Preparation System MGISP-960 MGISP-960, MGISP-960B2 refs 1 other Nucleic Acid Extraction and Purification System MGISP-100B	A IVDR	EUDAMED record Report an error
Ultrasound scanners - other	Z11040199	Robotic Ultrasound System (Doctor-end)MGIUS-R3D93/42 Robotic Ultrasound System (Patient-end) MGIUS-R3P Pro93/42 Robotic Ultrasound System (Patient-end) MGIUS-R3P93/42 Robotic Ultrasound System (Patient-end) MGIUS-R3P EXP93/42 Robotic Ultrasound System (Patient-end) MGIUS-R3P S93/42	IIa 93/42	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	HPV DNA Extraction Kit HD01T-96 Nucleic Acid Extraction Kit BDT-864 T-1728, T-96, OP02-32, VDR03P-32, VDR02P-96, VDR03P-96, SD01T-96, SD01T-1536, FDP-32, CDP-32, CDT-192, CDT-25, CDT-48, CDT-50, BDT-864, BDT-96, MD01T-96, WDT-96, WDT-8643 refs Sample Collection and Release Reagent SCR-100	A IVDR	EUDAMED record Report an error
Automated sample transport systems	W02060102	Sample Transfer Processing System MGISTP-3000 MGISTP-7000, MGISTP-3000, STP-B10003 refs	A IVDR	EUDAMED record Report an error
Autosamplers	W02069001	DNB Loader MGIDL-T7	A IVDR	EUDAMED record Report an error
Faeces collection devices	W05019001	Stool Collection Kit GSC02-I-15, GSC02-I-302 refs	A IVDR	EUDAMED record Report an error
Genetic system readers	W02050108	Genetic Sequencer DNBSEQ-G400 DNBSEQ-G50, DNBSEQ-G400, DNBSEQ-T7, DNBSEQ-G99, DNBSEQ-G99A, HELICON® G400, HELICON® G503 refs	A IVDR	EUDAMED record Report an error
Saliva collection devices	W05019002	Saliva Sample Collection Kit SSC022 refs	A IVDR	EUDAMED record Report an error

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