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EUDAMED last updated this device on Jun 1, 2026
697431813E-KitH4Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Nucleic Acid Extraction Kit MD01T-96 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Wuhan MGI Tech Co., Ltd.. Placed on the EU market in Latvia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →06974318130985Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →697431813E-KitH4940-000639-00UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →(01)06974318130985
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUSSterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Latvia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| LatviaPrimary placement | Still on market |
CN-MF-000018732No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.697431813MGISP-NEB4On the marketAutomated Nucleic Acid Extractor MGISP-NE384697431813MGISP-NEB4On the marketAutomated Nucleic Acid Extractor MGISP-NEX697431813MGISP-NEB4On the marketAutomated Sample Preparation System MGISP-Smart8697431813ASPSMVOn the marketAutomated Sequencing Library Preparation System GenSIRO-16697431813MGIFLPN2On the market