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Automated Flow Fluorescence Immunoassay Analyzer

EUDAMED

Class A (EU MDR)

Ref MY-0011-03Model MF1280Ref MY-0011-04Ref MY-0011-02

by Shenzhen Dymind Biotechnology Co., Ltd.

Identity

Trade Name
Automated Flow Fluorescence Immunoassay Analyzer EUDAMED
Device Name
Automated Flow Fluorescence Immunoassay Analyzer EUDAMED
Model / Reference
MF1280 EUDAMED
MY-0011-03 EUDAMED
MY-0011-04 EUDAMED
MY-0011-02 EUDAMED

Identifiers

Primary DI / UDI-DI
06976117454071 EUDAMED
06976117454088 EUDAMED
06976117454064 EUDAMED
Basic UDI-DI
697049309W020100000019F EUDAMED
Direct Marketing DI
06976117454071 EUDAMED
06976117454088 EUDAMED
06976117454064 EUDAMED
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany 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

Automated Flow Fluorescence Immunoassay Analyzer by Shenzhen Dymind Biotechnology 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 Dymind Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000024842
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (3)

  • EUDAMED 2f5fbada-b706-4cc9-9c15-115e4578a019 61 fields · synced Oct 6, 2026
  • EUDAMED 59694165-2698-402e-8802-87c0d93a190a 61 fields · synced May 18, 2026
  • EUDAMED b2248e2a-9329-4daf-b9a3-72bd9d6dae5b 61 fields · synced May 18, 2026