Identity
- Trade Name
- Fluent Dx 480 EUDAMED
- Device Name
- Fluent Dx EUDAMED
- Model / Reference
- 30042094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640137480257 EUDAMED
- Basic UDI-DI
- 764013748IVS10080001AEF EUDAMED
- EMDN Code
- W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER 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
Fluent Dx 480 by Tecan Schweiz AG — 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 | 764013748IVS10080001AEF | Class A | Active |
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Manufacturer
- Manufacturer
- Tecan Schweiz AG
- EUDAMED SRN
- CH-MF-000044877
- Authorised Representative
- Tecan Austria GmbH AT-AR-000044488
Sources (1)
- EUDAMED 28777425-4e8a-476c-8d36-b1035feb94c6 61 fields · synced Jul 31, 2026