Real time RT-PCR Kit for SARS-2 Flu A Flu B

by Gold Probe Diagnostic Biotechnology Inc. MF China EUDAMED

Ref 600160 EMDN W0105099004

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975977071602 Basic UDI-DI	Date19 Dec 2023Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Real time RT-PCR Kit for SARS-2 Flu A Flu B
Model / Reference: 600160

Primary DI / UDI-DI: 06975977071602
Basic UDI-DI: B-06975977071602
EMDN Code: W0105099004 Influenza a and /or b - rt & poc

Device Class: Class IVD General
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000031524
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Near-Patient Testing
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED 0e21f4b3-47f5-4434-818f-53f8d2c4161c 61 fields · synced 22 Oct 2026