EUDAMED last updated this device on Aug 14, 2026

T4 (Total Thyroxine) Rapid Quantitative Test

B-06975679490480

On the marketIVDD — General

Applicable legislation: —
Organization name: Hunan Ehome Health Technology 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 →: 06975679490480
Reference / catalog number: HU-RE-F07F040002

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.

T4 (Total Thyroxine) Rapid Quantitative Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hunan Ehome Health Technology Co., Ltd.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: T4 (Total Thyroxine) Rapid Quantitative Test
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 →: 06975679490480
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-06975679490480
Reference / catalog number: HU-RE-F07F040002
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 T4 (Total Thyroxine) Rapid Quantitative Test along with the Multi-functional Analyzer is intended for in vitro quantitative determination of Total Thyroxine (T4) in human serum or plasma. The test is used as an aid in the functional diagnosis of thyroidea.
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
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06975679490480

EMDN nomenclature code(s)

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

W01020407THYROXINE

Critical warnings

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

Refer to instruction manual/booklet

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Romania; available across 1 country total.

Country	On market since	Until
RomaniaPrimary placement	—	Still on market

T4 (Total Thyroxine) Rapid Quantitative Test

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Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

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

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

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Certificates covering this device

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