No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

WELLS BIO, INC.

SRN KR-MF-000031789

manufacturer · Seoul, KR · 14 devices

16, Magokjungang 8-ro 1-gil, 07795

Devices

Name	UDI-DI	Class	Badge
careGENE™ STD-12 detection kit	08809446080636	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careGENE™ STD-12 detection kit	08809446081879	Class C	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ G6PD Biosensor Analyzer	08809446080018	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ G6PD Biosensor Control Level I	08809446080698	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ G6PD Biosensor Control Level II	08809446080704	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ G6PD Biosensor Strip	08809446080988	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ Hb1 Analyzer	08809446082135	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ Hb1 Strip	08809446081992	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ Hb Biosensor Control	08809446081589	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ S1 Analyzer	08809446080131	Class A	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ S1 G6PD Strip	08809446080971	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ S1 Hb Strip	08809446080155	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ S1 Total Bilirubin Strip	08809446080162	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED
careSTART™ Total Bilirubin Biosensor Control	08809446080964	Unknown class	No Certificate Found Snapshot 2026-10-28 · Link to EUDAMED