Identity
- Trade Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Device Name
- Dry Fluorescence Immunoassay Analyzer EUDAMED
- Model / Reference
- FIC-S100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978747210003 EUDAMED
- Basic UDI-DI
- 697874721FIC-S1002M EUDAMED
- Direct Marketing DI
- 06978747210003 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Dry Fluorescence Immunoassay Analyzer by MaxBio (Tianjin) 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 | 697874721FIC-S1002M | Class A | Active |
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Manufacturer
- Manufacturer
- MaxBio (Tianjin) Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000048157
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 6ed9f7da-8b35-4e39-9f56-bde7087cf754 61 fields · synced Jun 18, 2026