EUDAMED last updated this device on Aug 14, 2026

Estradiol Rapid Quantitative Test

B-06975679490367

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 →: 06975679490367
Reference / catalog number: HU-RE-F07F063002

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.

Estradiol 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 Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Estradiol 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 →: 06975679490367
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-06975679490367
Reference / catalog number: HU-RE-F07F063002
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 Estradiol (E2) Rapid Quantitative Test along with Multi-functional Analyzer is intended for in vitro quantitative determination of Estradiol in human serum or plasma.
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)06975679490367

EMDN nomenclature code(s)

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

W0102050202ESTRIOL

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	—	Still on market

Estradiol Rapid Quantitative Test

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

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

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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