- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on May 20, 2026
697431271MEYUFully Automatic ELISA Analyzer is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Changsha Imadek Intelligent Technology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000042852(01)06974312710220
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
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.
Primary placement in Germany; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | May 20, 2026 | May 20, 2066 |
| EL | May 20, 2026 | May 20, 2066 |
| Spain | May 20, 2026 | May 20, 2066 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974312710220Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
697431271MEYUME-8800LUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W02010299IMMUNOCHEMISTRY INSTRUMENTS - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →697431271MEYUOn the marketFully Automatic ELISA Analyzer697431271MEYUOn the marketFully Automatic ELISA Analyzer697431271MEYUOn the marketSample Processing System697431271003H6On the marketSample Processing System697431271003H6On the marketSample Processing System697431271005HAOn the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.