Follicle-stimulating Hormone (FSH) (Light-initiated Chemiluminescence Immunoassay, LiCA)

by Chemclin Diagnostics Co., Ltd. 4 variants

Ref 05010301332Model 2 × 50 Tests; 2 × 100 Tests; 4 × 50 Tests; 4 × 100 Tests

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number6978364380004FA Basic UDI-DI 06973864380035UDI-DI	Date6 May 2023Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: Follicle-stimulating Hormone (FSH) (Light-initiated Chemiluminescence Immunoassay, LiCA)
Model / Reference: 2 × 50 Tests, 2 × 100 Tests, 4 × 50 Tests, 4 × 100 Tests, 05010301332

Primary DI / UDI-DI: 06973864380035
Basic UDI-DI: 6978364380004FA
Direct Marketing DI: 06973864380035
EMDN Code: W0102050104 Follicle stimulating hormone

Device Class: Class B
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000009729
Authorised representative: MedNet EC-REP GmbH DE-AR-000000002

Other devices from Chemclin Diagnostics Co., Ltd.

Properties

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