EUDAMED last updated this device on Aug 12, 2026

25-OH-VD Rapid Quantitative Test

B-06975679490404

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 →: 06975679490404
Reference / catalog number: HU-RE-F08F027002

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.

25-OH-VD 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: 25-OH-VD 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 →: 06975679490404
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-06975679490404
Reference / catalog number: HU-RE-F08F027002
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 product is used to detect the content of 25-OH-VD in human serum/plasma /whole blood. 25-Hydroxyvitamin D is the main form of vitamin D in the body. Vitamin D is a derivative of steroids and belongs to-soluble vitamins. Vitamin D is mainly synthesized by human skin after ultraviolet irradiation, and a small part is ingested from food or supplements. There are forms of vitamin D in the human body, vitamin D (cholecalciferol) and vitamin D (ergocalciferol) , and vitamin D converted into 25-hydroxyvitamin D (25-OH-VD) in the liver through hydroxylation. Vitamin D is an essential substance for maintaining health, cell growth and development, and is closely related to a variety of diseases, and the level of 25-OH-VD in serum can reflect the level of vitamin D in the human body. Clinically, it is mainly used as an auxiliary diagnosis of vitamin D deficiency related diseases. Serum 25-hydroxyvit D levels can be used as an indicator for evaluating osteoporosis and fracture risk. Rickets is a disease caused by calciumization disorders of bones due to vitamin deficiency during growth and development. At present, the methods for detecting 25-hydroxyvitamin D in China include chemiluminescence and immunofluorescence,etc.
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)06975679490404

EMDN nomenclature code(s)

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

W0102070206VITAMIN D (CHOLECALCIFEROL)

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

25-OH-VD 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

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 covering this device

Related devices

Certificates