Identity
- Device Name
- FIA Analyzer FLI-100 EUDAMED
- Model / Reference
- FLI-100 EUDAMEDBT0106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933260209064 EUDAMED
- Basic UDI-DI
- 69332602IT01000029T EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
FIA Analyzer FLI-100 by Xiamen Biotime 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 | 69332602IT01000029T | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Biotime Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000012852
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 01d8d0c5-5510-4bfd-a699-93d3f9d5273e 61 fields · synced Oct 6, 2026