Data from EUDAMED, last updated Jun 11, 2026

Breast cancer–associated gene mutation digital PCR detection kit

B-06974689627305

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: TargetingOne Technology (Beijing) Corporation

Device family identification

Device name: Breast cancer–associated gene mutation digital PCR detection kit
Basic UDI-DI: B-06974689627305
Device model: BC01-Y12
Issuing agency: EUDAMED
Version date: May 12, 2026

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentProfessional 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
Breast cancer–associated gene mutation digital PCR detection kit	`12696--2`	`06974689627305`	1	On the market