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Free Prostate Specific Antigen (FPSA) (Light-initiated Chemiluminescence Immuno…

EUDAMED

Class C (EU MDR)

Ref 12010108821 Model 2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 TestsRef 12010108820 Ref 12010108823

by Chemclin Diagnostics Co., Ltd.

Identity

Device Name
Free Prostate Specific Antigen (FPSA) (Light-initiated Chemiluminescence Immunoassay, LiCA) EUDAMED
Model / Reference
2 × 100 Tests, 2 × 200 Tests, 4 × 100 Tests, 4 × 200 Tests EUDAMED
12010108821 EUDAMED
12010108820 EUDAMED
12010108823 EUDAMED

Identifiers

Primary DI / UDI-DI
06973864381803 EUDAMED
06973864381780 EUDAMED
06973864381810 EUDAMED
Basic UDI-DI
6973864380084F4 EUDAMED
Direct Marketing DI
06973864381803 EUDAMED
06973864381780 EUDAMED
06973864381810 EUDAMED
EMDN Code
W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Czechia EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Free Prostate Specific Antigen (FPSA) (Light-initiated Chemiluminescence Immuno… by Chemclin Diagnostics Co., Ltd. — Class C — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Chemclin Diagnostics Co., Ltd.
EUDAMED SRN
CN-MF-000009729
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (3)

  • EUDAMED afffbe00-c378-4244-8638-5e43068e70d8 61 fields · synced Jul 30, 2026
  • EUDAMED e4c72148-06be-422b-a45b-5fa12ec16149 61 fields · synced May 17, 2026
  • EUDAMED e7b5f760-bce6-457c-b427-76f237ffee8e 61 fields · synced May 19, 2026