Data from EUDAMED, last updated Jun 11, 2026

Fully Automatic ELISA Analyzer

697431271MEYU

26 references

IVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class A
Manufacturer: Changsha Imadek Intelligent Technology Co., Ltd.

Device family identification

Device name: Fully Automatic ELISA Analyzer
Basic UDI-DI: 697431271MEYU
Device model: ME-1000 ME-2000、ME-2000Plus、ME-2000Pro、ME-4000、ME-4000Plus、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro ME-8800M、ME-8800S、ME-8800
Issuing agency: GS1
Version date: May 15, 2026

Classification

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class A
Status: On the market

Manufacturer & authorised representative

Manufacturer

Name: Changsha Imadek Intelligent Technology Co., Ltd.
SRN: CN-MF-000042852
Country: China
Email: huchunyan@csmadik.com.cn

Authorised representative

Name: Sungo Cert GmbH
SRN: DE-AR-000010869
Country: Germany

Device characteristics

Professional testing

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

W02010299Immunochemistry instruments - other

References by status

Device family identification

Device name: Fully Automatic ELISA Analyzer
Basic UDI-DI: 697431271MEYU
Device model: ME-1000 ME-2000、ME-2000Plus、ME-2000Pro、ME-4000、ME-4000Plus、ME-4000Pro ME-4800、ME-4800Plus、ME-4800Pro、ME-8000、ME-8000Plus、ME-8000Pro 、ME-8400、ME-8400Plus、ME-8400Pro ME-8800M、ME-8800S、ME-8800
Issuing agency: GS1
Version date: May 15, 2026

References

26 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Fully Automatic ELISA Analyzer	`ME4800Pro`	`06974312710091`	1	On the market
Fully Automatic ELISA Analyzer	`ME-2000Pro`	`06974312710039`	1	On the market
Fully Automatic ELISA Analyzer	`ME-2000`	`06974312710015`	1	On the market
Fully Automatic ELISA Analyzer	`ME-4000`	`06974312710046`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8400Plus`	`06974312710145`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800D`	`06974312710190`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800LPlus`	`06974312710237`	1	On the market
Fully Automatic ELISA Analyzer	`ME-1000`	`06974312710008`	1	On the market
Fully Automatic ELISA Analyzer	`ME-4800`	`06974312710077`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8000Pro`	`06974312710121`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800DPro`	`06974312710213`	1	On the market
Fully Automatic ELISA Analyzer	`ME-4800Plus`	`06974312710084`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8000`	`06974312710107`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800`	`06974312710169`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800M`	`06974312710183`	1	On the market
Fully Automatic ELISA Analyzer	`ME-4000Plus`	`06974312710053`	1	On the market
Fully Automatic ELISA Analyzer	`ME-4000Pro`	`06974312710060`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8000Plus`	`06974312710114`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800LPro`	`06974312710244`	1	On the market
Fully Automatic ELISA Analyzer	`ME-2000Plus`	`06974312710022`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800DPlus`	`06974312710206`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800S`	`06974312710176`	1	On the market
Fully Automatic ELISA Analyzer	`ME-2800`	`06974312710251`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8800L`	`06974312710220`	1	On the market
Fully Automatic ELISA Analyzer	`ME-8400Pro`	`06974312710152`	1	On the market