Identity
- Trade Name
- FIAPro™ Immunofluorescence Analyzer EUDAMED
- Device Name
- Immunofluorescence Analyzer EUDAMED
- Model / Reference
- VMFIA1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548252289 EUDAMED
- Basic UDI-DI
- 86835482FIAPro2V EUDAMEDB-08683548252289 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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
FIAPro™ Immunofluorescence Analyzer by Vitrosens Biotechnology Inc. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 86835482FIAPro2V | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 86835482FIAPro2V | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 205ae23d-3eb8-43cb-a1bc-608209ea4390 61 fields · synced Jul 8, 2026
- EUDAMED 4c09e745-8998-4a0c-b7aa-e168df29c8b4 61 fields · synced May 18, 2026