MONOGENETIC DISORDERS TESTS - OTHER

EMDN W0106010199

Registry term list. Not a clinical opinion. 287 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
SMART SNP MTHFR 1298 Direct Kit	08057723370097	BIOCLARMA S.R.L.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SMART SNP MTHFR 1298 Positive Control	08057723370615	BIOCLARMA S.R.L.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SMART SNP MTHFR 677 Direct Kit	08057723370103	BIOCLARMA S.R.L.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)	06955931303031	Yaneng BIOscience (Shenzhen) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Spinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing）	06955931303024	Yaneng BIOscience (Shenzhen) Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Spinal muscular atrophy (SMA) digital PCR detection kit	06974689626100	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Spinal muscular atrophy (SMA) digital PCR detection kit	06974689627091	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC & KREC Screening Kit	37350134361183	ImmunoIVD AB	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC & KREC Screening Kit	47350134361180	ImmunoIVD AB	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC, KREC & SMN1 Screening Kit	37350134361794	ImmunoIVD AB	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC, KREC & SMN1 Screening Kit	47350134361791	ImmunoIVD AB	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC Screening Kit	37350134361176	ImmunoIVD AB	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC Screening Kit	47350134361173	ImmunoIVD AB	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC & SMN1 Screening Kit	37350134361787	ImmunoIVD AB	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
SPOT-it TREC & SMN1 Screening Kit	47350134361784	ImmunoIVD AB	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)	00810173656993	Healgen Scientific Limited Liability Company	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)	00810173657006	Healgen Scientific Limited Liability Company	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)	06950996004534	Zhejiang Orient Gene Biotech Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TaqPath™ Menu \| GeneProof™ Factor XIII V34L PCR Kit	08595696304294	GeneProof a.s.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Targeted qPCR SMA	05430002471747	LaCAR MDx Technologies	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Targeted qPCR SMA	05430003908266	LaCAR MDx Technologies	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Targeted qPCR SMA FLEX	05430002471754	LaCAR MDx Technologies	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit	06974870710274	Wuxi Ruiqi Gene Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit	06974870710281	Wuxi Ruiqi Gene Biotechnology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ThromboType®plus VER 3.0	04049055001149	Hain Lifescience GmbH	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TRUPCR® HLA B-27 Real-Time PCR Kit	08906213930450	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TRUPCR® HLA B-27 Real-Time PCR Kit	08906213930467	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TRUPCR® HLA B-27 Real-Time PCR Kit	08906213930474	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TRUPCR® MTHFR Mutation Detection Kit	08906213930542	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TRUPCR® MTHFR Mutation Detection Kit	08906213930559	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
TRUPCR® MTHFR Mutation Detection Kit	08906213930566	3B BlackBio Dx Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
VERACITY Premium	05298004820044	MEDICOVER GENETICS LIMITED	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
VitaSIRO solo MT-RNR1 SNP Assay	04719878570602	Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ZENA MAX Factor V R2 Polymorphism Real Time PCR Detection Kit	05061059980298	Advanced Molecular Diagnostics Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ZENA MAX Janus Kinase 2 (JAK2) V617F Real Time PCR Detection Kit	05061059980250	Advanced Molecular Diagnostics Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ZENA MAX MTHFR (A1298C) Real Time PCR Detection Kit	05061059980243	Advanced Molecular Diagnostics Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ZENA MAX MTHFR C677T Real Time PCR Detection Kit	05061059980236	Advanced Molecular Diagnostics Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED