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Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immuno…

EUDAMED

Class C (EU MDR)

Ref 12010107823Model 2 × 100 Tests; 2 × 200 Tests; 4 × 100 Tests; 4 × 200 TestsRef 12010107821Ref 12010107822Ref 12010107820

by Chemclin Diagnostics Co., Ltd.

Identity

Device Name
Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA) EUDAMED
Model / Reference
2 × 100 Tests; 2 × 200 Tests; 4 × 100 Tests; 4 × 200 Tests EUDAMED
12010107823 EUDAMED
12010107821 EUDAMED
12010107822 EUDAMED
12010107820 EUDAMED

Identifiers

Primary DI / UDI-DI
06973864382404 EUDAMED
06973864382398 EUDAMED
06973864382381 EUDAMED
06973864382374 EUDAMED
Basic UDI-DI
6978364380097GB EUDAMED
Direct Marketing DI
06973864382404 EUDAMED
06973864382398 EUDAMED
06973864382381 EUDAMED
06973864382374 EUDAMED
EMDN Code
W0102030113 TOTAL PROSTATIC SPECIFIC ANTIGEN EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Germany 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

Total Prostate Specific Antigen (PSA) (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 (4)

  • EUDAMED f619e501-3bbc-447e-af7c-a1404ea68ca9 61 fields · synced Sep 18, 2026
  • EUDAMED df2a0328-7fa9-48dd-a28e-727911f11931 61 fields · synced May 18, 2026
  • EUDAMED f0f02cc3-d9f5-4b5b-a9fb-0045a09879c5 61 fields · synced May 19, 2026
  • EUDAMED 23ffb8f8-3915-465d-b16c-6f2e43835f97 61 fields · synced May 19, 2026