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Anti-Streptolysin O (aso)
EUDAMEDClass IVD General (EU MDR)
Ref 31031Ref 23923Ref 31923Ref 13923
Identity
- Device Name
- ANTI-STREPTOLYSIN O (ASO) EUDAMED
- Model / Reference
- 31031 EUDAMED23923 EUDAMED31923 EUDAMED13923 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287110319 EUDAMED08435287102352 EUDAMED08435287119237 EUDAMED08435287139235 EUDAMED
- Basic UDI-DI
- B-08435287110319 EUDAMEDB-08435287102352 EUDAMEDB-08435287119237 EUDAMEDB-08435287139235 EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Anti-Streptolysin O (aso) by Biosystems S.a. — 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-08435287110319 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED cfce5e16-d754-4d96-b6de-0b180e311483 61 fields · synced Aug 3, 2026
- EUDAMED 1a2d0667-283c-419d-afdf-199f08250007 61 fields · synced May 18, 2026
- EUDAMED 4f3f757b-985a-4a99-a6e2-e579cc40424b 61 fields · synced May 18, 2026
- EUDAMED 0c73963b-8274-4dde-8a49-2fcbddd6eb7f 61 fields · synced May 18, 2026