Respiratory multiple 7 in 1 test kit - MP

EUDAMED

Class B (EU MDR)

Ref 303041901

by Hangzhou Laihe Biotech Co., Ltd.

Identity

Device Name: Respiratory multiple 7 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV) EUDAMED
Model / Reference: 303041901 EUDAMED

Identifiers

Primary DI / UDI-DI: 06972412611478 EUDAMED
Basic UDI-DI: 0697241261IRS-572BQ EUDAMED
EMDN Code: W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Models / Variants: FluA EUDAMED
FluB EUDAMED
COVID-19 EUDAMED
RSV EUDAMED
Adeno EUDAMED
MP EUDAMED
HMPV EUDAMED

Classification

Device Class: Class B EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Respiratory multiple 7 in 1 test kit - MP by Hangzhou Laihe Biotech Co., Ltd. — Class B — IVDR — listed in EUDAMED — 7 models — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	0697241261IRS-572BQ	Class B	Active

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Manufacturer

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
EUDAMED SRN: CN-MF-000033566
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED 500f7c63-abb4-4acb-8299-6642c1b375f9 61 fields · synced Jun 20, 2026