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Chemiluminescence Immunoassay Analyzer

EUDAMED

Class A (EU MDR)

Ref C6110Model iFlash 3000-CRef FG0074Model iFlash 1200-ARef C6109

by Shenzhen Yhlo Biotech Co., Ltd.

Identity

Device Name
Chemiluminescence Immunoassay Analyzer EUDAMED
Model / Reference
iFlash 3000-C EUDAMED
C6110 EUDAMED
iFlash 1200-A EUDAMED
FG0074 EUDAMED
C6109 EUDAMED

Identifiers

Primary DI / UDI-DI
06925912710516 EUDAMED
06925912715276 EUDAMED
06925912710479 EUDAMED
Basic UDI-DI
692591270141H4 EUDAMED
692591270115H3 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
Italy EUDAMED
Cyprus 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

Chemiluminescence Immunoassay Analyzer by Shenzhen Yhlo Biotech 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
Shenzhen Yhlo Biotech Co., Ltd.
EUDAMED SRN
CN-MF-000001137
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (3)

  • EUDAMED 0de019c7-7784-4ab1-aacb-a2c145b0b3ee 61 fields · synced Jul 31, 2026
  • EUDAMED e05219b5-2ac9-43e6-a213-c44c3137b5d2 61 fields · synced May 16, 2026
  • EUDAMED 4fbb3edc-a21e-45f1-a340-b198a04aa47f 61 fields · synced May 18, 2026