Identity
- Trade Name
- ANTI-STREPTOLYSIN O EUDAMED
- Device Name
- ANTI-STREPTOLYSIN O EUDAMED
- Model / Reference
- ASLO-4001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700801238 EUDAMED
- Basic UDI-DI
- B-03701700801238 EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
Anti-Streptolysin O by Vitalscientific — 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-03701700801238 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (1)
- EUDAMED ac82d06b-acfc-4770-a1ce-2adba8d4adf3 61 fields · synced May 23, 2026