Total β- Human Chorionic Gonadotropin (CLIA)

by Medcaptain Medical Technology Co., Ltd. United States EUDAMED

Ref MCL05801E EMDN W0102050205

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	Number69268026MD761F0000000013C Basic UDI-DI	Date25 Jun 2026Registered	StatusActive
European Union	CE/IVDR	Number69268026MD761F0000000013C Basic UDI-DI	Date25 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name: Total β- Human Chorionic Gonadotropin (CLIA)
Total β-Human Chorionic Gonadotropin (CLIA)
Model / Reference: MCL05801E

Primary DI / UDI-DI: 06926802605356
Basic UDI-DI: 69268026MD761F0000000013C, B-06926802605356
EMDN Code: W0102050205 Total human chorionic gonadotropin

Device Class: Class C
Class IVD General
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000005925
Authorised representative: R Sight B.V. NL-AR-000010445

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Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Animal Tissues
Reagent
Professional Testing

Other properties (7)

Sterile: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No

Sources (2)

EUDAMED 06926802605356|69268026MD761F0000000013C 61 fields · synced 25 Oct 2026
EUDAMED 06926802605356|B-06926802605356 61 fields · synced 25 Oct 2026