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Automated Flow Fluorescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref MY-0011-01Model MF1280
Identity
- Trade Name
- Automated Flow Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Automated Flow Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- MF1280 EUDAMEDMY-0011-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454057 EUDAMED
- Basic UDI-DI
- 697049309W020100000019F EUDAMED
- Direct Marketing DI
- 06976117454057 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697049309W020100000019F | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 345dead9-03fb-477f-a68e-1bcb8516e762 61 fields · synced Jun 19, 2026