EUDAMED last updated this device on Jun 8, 2026

GS121104C01

B-06977903346617

On the marketIVDD — General

Applicable legislation: —
Organization name: GeneSign Biotech (Xiamen)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 →: 06977903346617
Reference / catalog number: GS121104C01

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.

GS121104C01 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by GeneSign Biotech (Xiamen)Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: not provided
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 →: 06977903346617
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-06977903346617
Reference / catalog number: GS121104C01
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: The FA FIA is a lateral flow fluorescence immunoassay intended for quantitative detection of N Immunoglobulin E (FA), together with the FIA Analyzer in human whole blood, serum, or plasma specimens. It is intended to be used by healthcare professionals as an aid in diagnosis and management of allergic disease. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

UDI-DI DataMatrix

Encoded

(01)06977903346617

EMDN nomenclature code(s)

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

W01021699RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	—	Still on market
Italy	—	Still on market

GS121104C01

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Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

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Regulatory

Lifecycle

Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

Regulatory

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Certificates

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Certificates covering this device

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Certificates