EUDAMED last updated this device on Jun 30, 2026

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

B-06950996004534

On the marketIVDD — General

Applicable legislation: —
Organization name: Zhejiang Orient Gene Biotech Co., Ltd
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06950996004534
Reference / catalog number: N7001A

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06950996004534
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06950996004534
Reference / catalog number: N7001A
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — General
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: This kit is used for in vitro quantitative detection for copy number of exon 7 of survival motor neuron 1 (SMN1) and exon 7 of survival motor neuron 2 (SMN2) in human EDTA anticoagulated whole blood specimen, dried blood spot specimen, oropharyngeal swab and saliva. The test results are only used for the purpose of auxiliary diagnosis of Spinal Muscular Atrophy (SMA), and should be comprehensively considered in conjunction with the patient's clinical diagnosis and other laboratory tests.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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UDI-DI DataMatrix

Encoded

(01)06950996004534

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0106010199MONOGENETIC DISORDERS TESTS - OTHER

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

Please refer to the IFU.
OTHER

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New device

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	—	Still on market

Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)

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