Urinalysis Specific Gravity Calibrator

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref HU5181001

EMDN W010106020602

Regulatory status

as of 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-HU5181001NU 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 22 Oct 2026

Device Name: Urinalysis Specific Gravity Calibrator
Model / Reference: HU5181001

Primary DI / UDI-DI: D-HU5181001NU
Basic UDI-DI: B-HU5181001NU
EMDN Code: W010106020602 Urine testing calibrators and standards

Device Class: Class IVD General
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Humiss International B.V. NL-AR-000001490

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Properties & raw data

Show properties, registry sources and raw records

Professional Testing

Other properties (9)

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

Sources (1)

EUDAMED 9831f9fd-ebe9-4ace-ac40-19f5d21af8ff 61 fields · synced 22 Oct 2026