Data from EUDAMED, last updated Jun 11, 2026

Strep A Rapid Test

69528048A463101ZT

1 reference

IVDR Class B

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

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

Near-patient testingProfessional testing

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

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Strep A Rapid Test Device	`A46310120`	`06952804809720`	1	On the market