EUDAMED last updated this device on Jul 21, 2026

LYHER

0697241261IRS-572BQ

On the marketIVDR Class B

Applicable legislation: —
Organization name: Hangzhou Laihe 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 →: 06972412611478
Reference / catalog number: 303041901-25

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.

LYHER is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Hangzhou Laihe Biotech Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: LYHER
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 →: 06972412611478
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 →: 0697241261IRS-572BQ
Reference / catalog number: 303041901-25
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: IVDR Class B
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The Respiratory multiple 7 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV) is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, influenza A virus, influenza B virus, respiratory syncytial virus (RSV) Adenovirus Mycoplasma pneumoniae or human metapneumovirus in nasopharyngeal swab, oropharyngeal swab or nasal swab specimens. The device detects any combination of the above viruses. Antigen tests are generally used for acute phase of infection, this test detects the antigen in specimen from individuals who are suspected of relative virus infection within 7 days of symptom onset. This test only provides an aid to diagnosis of novel coronavirus (SARS-CoV-2), influenza A virus, influenza B virus, RSV, Adenovirus Mycoplasma pneumoniae infection and human metapneumovirus infection. The infection status should be determined in combination with other diagnostic information such as PCR tests or medical image science, exposures and medical history. Positive results only indicate the presence of viral antigens in specimens and cannot determine the infection status. Positive results can be used for patient diversion and rapid management decisions. Negative results cannot rule out the SARS-CoV-2, influenza A virus, influenza B virus, RSV, Adenovirus Mycoplasma pneumoniae infection or human metapneumovirus infection, and should not be used as sole basis for treatment or patient management decisions. Both positive and negative results for suspected cases should be determined by a further molecular assay (e.g., PCR test).
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)06972412611478

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

W0105090699OTHER MULTIPLE PATHOGENS - RT & POC

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 1 country total.

Country	On market since	Until
SpainPrimary placement	Nov 3, 2025	Nov 3, 2030

LYHER

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UDI-PI traceability

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UDI-PI DataMatrix

EMDN nomenclature code(s)

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