SARS-COV-2 viral RNA detection kit(real-time RT-PCR method)

EUDAMED

Class IVD General (EU MDR)

Ref 48 tests/kit

by Guangzhou LBP Medicine Science & Technology Co., Ltd.

Identity

Device Name: SARS-COV-2 viral RNA detection kit(real-time RT-PCR method) EUDAMED
Model / Reference: 48 tests/kit EUDAMED

Identifiers

Primary DI / UDI-DI: 06948500931797 EUDAMED
Basic UDI-DI: B-06948500931797 EUDAMED
EMDN Code: W010699 GENETIC TESTS - OTHER EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Netherlands EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMED

Surgical Instrument

EUDAMED

SARS-COV-2 viral RNA detection kit(real-time RT-PCR method) by Guangzhou LBP Medicine Science & Technology Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06948500931797	Class IVD General	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Guangzhou LBP Medicine Science & Technology Co., Ltd.
EUDAMED SRN: CN-MF-000026786
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED f7dbf6d0-c9f0-4d70-8c5f-754542c1a173 61 fields · synced Oct 6, 2026