Data from EUDAMED, last updated Jun 11, 2026

DE-MAR、DE-MIR、DE-LIN

697721162HSDCSLD

3 references

IVDR Class A

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

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

Professional testing

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

Data from EUDAMED, last updated Jun 11, 2026

697721162HSDCSLD

3 references

IVDR Class A

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

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

Professional testing

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
DE-MIR	`DE-MIR`	`06977211620034`	1	On the market
DE-MAR	`DE-MAR`	`06977211620027`	1	On the market
DE-LIN	`DE-LIN`	`06977211620041`	1	On the market