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Automatic Chemiluminescence Analyzer

EUDAMED

Class A (EU MDR)

Ref EIM9402025Model i 6000Ref EIM9401007Model i 1000； i 1000L； i 1000S

by Maccura Medical Instrument Co., Ltd.

Identity

Trade Name
Automatic Chemiluminescence Analyzer EUDAMED
Device Name
Automatic Chemiluminescence Analyzer EUDAMED
Model / Reference
i 6000 EUDAMED
EIM9402025 EUDAMED
i 1000； i 1000L； i 1000S EUDAMED
EIM9401007 EUDAMED

Identifiers

Primary DI / UDI-DI
06972168353806 EUDAMED
06972168355527 EUDAMED
Basic UDI-DI
69721683511049V EUDAMED
69721683511029R EUDAMED
Direct Marketing DI
06972168353806 EUDAMED
06972168355527 EUDAMED
EMDN Code
W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Automatic Chemiluminescence Analyzer by Maccura Medical Instrument Co., Ltd. — Class A — 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
Maccura Medical Instrument Co., Ltd.
EUDAMED SRN
CN-MF-000028087
Authorised Representative
Humiss International B.V. NL-AR-000001490

Sources (2)

  • EUDAMED 12671603-3292-4fd2-a57b-2d419435a7f2 61 fields · synced Oct 6, 2026
  • EUDAMED 9c8ddc3d-8b92-4725-916d-bbee2504fa23 61 fields · synced May 19, 2026