Urinalysis Specific Gravity Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref HU5192008

EMDN W010106020601

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-HU5192008PU 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 24 Oct 2026

Device Name: Urinalysis Specific Gravity Control
Model / Reference: HU5192008

Primary DI / UDI-DI: D-HU5192008PU
Basic UDI-DI: B-HU5192008PU
EMDN Code: W010106020601 Urine testing controls

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 5b94971c-4e09-4b14-9d43-681845d767c4 61 fields · synced 24 Oct 2026