Identity
- Device Name
- ASO Antistreptolysin ‘O’ Latex Test Kit EUDAMED
- Model / Reference
- 41LA300-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904226001457 EUDAMED
- Basic UDI-DI
- 8904226041LA300U3 EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Austria 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
New Device
No
EUDAMED
ASO Antistreptolysin ‘O’ Latex Test Kit by ARKRAY Healthcare Pvt. Ltd. — Class B — 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 | 8904226041LA300U3 | Class B | Active |
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Manufacturer
- Manufacturer
- ARKRAY Healthcare Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000019015
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (1)
- EUDAMED 712d43d0-a1da-492d-9f65-d41f6b0d376d 61 fields · synced Jun 19, 2026