Identity
- Trade Name
- NOVEOS flex Immunoassay System EUDAMED
- Device Name
- NOVEOS® Immunoassay System EUDAMED
- Model / Reference
- FX64000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816879028768 EUDAMED
- Basic UDI-DI
- 081687902NOVINST37 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
NOVEOS flex Immunoassay System by Hycor Biomedical Llc — 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 | 081687902NOVINST37 | Class A | Active |
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Manufacturer
- Manufacturer
- Hycor Biomedical LLC
- EUDAMED SRN
- US-MF-000031449
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e385c53f-47eb-4c31-b165-5249e00ddf8f 61 fields · synced Jun 20, 2026