Data from EUDAMED, last updated May 23, 2026

Optitrol Orange

426046567SROrange4T

3 references

IVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Manufacturer: DiaMex GmbH

Device family identification

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

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

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

Data from EUDAMED, last updated May 23, 2026

426046567SROrange4T

3 references

IVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Manufacturer: DiaMex GmbH

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

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

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

3 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
SR11061	`SR11061`	`4260465670316`	1	On the market
SR11063	`SR11063`	`4260465670323`	1	On the market
SR11069	`SR11069`	`4260465670330`	1	On the market