Identity
- Device Name
- abOne™ Viral DNA and RNA Extraction Kit EUDAMED
- Model / Reference
- 800941 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885019711084 EUDAMED
- Basic UDI-DI
- 888501971800941XF EUDAMED
- EMDN Code
- W0105900103 SUPPLEMENTAL NA REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
abOne™ Viral DNA and RNA Extraction Kit by AITbiotech Pte Ltd — 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 | 888501971800941XF | Class A | Active |
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Manufacturer
- Manufacturer
- AITbiotech Pte Ltd
- EUDAMED SRN
- SG-MF-000003510
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED b5e9edef-02d2-40ec-be42-43eeffff2b51 61 fields · synced Jun 18, 2026