Identity
- Trade Name
- AQUIOS Designer Software EUDAMED
- Device Name
- AQUIOS Designer Software EUDAMED
- Model / Reference
- B69476 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590716677 EUDAMED
- Basic UDI-DI
- 150995902FCADSSWHL EUDAMED
- EMDN Code
- W0202040182 CYTOFLOWMETERS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
New Device
No
EUDAMED
AQUIOS Designer Software by Beckman Coulter Ireland Inc. — 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 | 150995902FCADSSWHL | Class A | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED 044ed06e-487f-4a36-b9a2-b4a46e820bc1 61 fields · synced Oct 6, 2026