Pct (Clia)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4405301

EMDN W0102069013

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4405301J4 Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name: Pct (Clia)
Model / Reference: IM4405301

Primary DI / UDI-DI: D-IM4405301J4
Basic UDI-DI: B-IM4405301J4
EMDN Code: W0102069013 Procalcitonin

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (6)

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

Sources (1)

EUDAMED 8a0d98c8-1abf-46a4-8554-22dbde0befec 61 fields · synced 23 Oct 2026