Monkeypox Virus Fluorescent PCR Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref GN7102110Model 32 Tests EMDN W0105070502

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06950617490951 Basic UDI-DI	Date14 Sep 2024Registered	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Withdrawn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

Model / Reference: 32 Tests, GN7102110

Primary DI / UDI-DI: 06950617490951
Basic UDI-DI: B-06950617490951
EMDN Code: W0105070502 Other multiple infectious - multiplex na reagents

Device Class: Class IVD General
Market of Registration: Türkiye

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED cfbeb041-d5ff-4672-84d6-8c49faf911ea 61 fields · synced 22 Oct 2026