Identity
- Trade Name
- ASO-Q EUDAMEDASO-Q - Biotecnica Systems EUDAMED
- Device Name
- ASO-Q EUDAMEDASO-Q - Biotecnica Systems EUDAMED
- Model / Reference
- 7781 EUDAMEDBT7731 EUDAMED7709 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172971724 EUDAMED08053172972950 EUDAMED08053172971694 EUDAMED
- Basic UDI-DI
- B-08053172971724 EUDAMEDB-08053172972950 EUDAMEDB-08053172971694 EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMEDW01021106 ANTI-STAPHYLOLYSIN (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Aso-Q by Giesse Diagnostics Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08053172971724 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (3)
- EUDAMED 0c6c05df-f39c-4d93-945b-f99354c5f78c 61 fields · synced Jul 26, 2026
- EUDAMED e2f0da71-74b6-4f74-86a3-6de11b952a74 61 fields · synced May 18, 2026
- EUDAMED dac00509-96dd-4aaf-b094-cfe119b804f2 61 fields · synced May 18, 2026