Data from EUDAMED, last updated May 24, 2026

Norma-iOptiClean

59991062iOptiCleanC4

4 references

IVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class A
Manufacturer: NORMA Instruments Zártkörűen Működő Részvénytársaság

Device family identification

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

ReagentProfessional testing

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

References

4 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
H5-Opticlean	`HE3422`	`05999106200528`	1	On the market
H5-Opticlean	`HE3422`	`05999106200856`	1	On the market
Norma-iOptiClean	`IC-81750`	`05999106200610`	1	On the market
Norma-iOptiClean	`IC-81750`	`05999106200238`	1	On the market