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INNODX f-PSA CMIA

EUDAMED

Class C (EU MDR)

Ref KR-f-PSA-02100Ref KR-f-PSA-01200Ref KR-f-PSA-0250Ref KR-f-PSA-0150Ref KR-f-PSA-01100

by Xiamen Innodx Biotech Co., Ltd.

Identity

Trade Name
INNODX f-PSA CMIA EUDAMED
Device Name
INNODX f-PSA CMIA EUDAMED
Model / Reference
KR-f-PSA-02100 EUDAMED
KR-f-PSA-01200 EUDAMED
KR-f-PSA-0250 EUDAMED
KR-f-PSA-0150 EUDAMED
KR-f-PSA-01100 EUDAMED

Identifiers

Primary DI / UDI-DI
06973600799282 EUDAMED
06973600799268 EUDAMED
06973600799275 EUDAMED
06973600799251 EUDAMED
06973600798414 EUDAMED
Basic UDI-DI
697360079023JT EUDAMED
EMDN Code
W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

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

INNODX f-PSA CMIA by Xiamen Innodx Biotech Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Xiamen Innodx Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000041071
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (5)

  • EUDAMED eac1eed9-fec9-434a-a2c5-87278a65f399 61 fields · synced Oct 7, 2026
  • EUDAMED 38ad0de8-1433-47af-ab16-228446e6219f 61 fields · synced May 18, 2026
  • EUDAMED dfc1df4d-0844-44a4-b595-229d67e45359 61 fields · synced May 18, 2026
  • EUDAMED a6a66f40-3071-4d12-a3f4-b46bb7024d14 61 fields · synced May 18, 2026
  • EUDAMED 3ca4d175-af01-4acb-8c14-c728530baa8c 61 fields · synced May 19, 2026