Identity
- Device Name
- abONE™ Tip Cartridge Set EUDAMED
- Model / Reference
- 800953 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885019711114 EUDAMED
- Basic UDI-DI
- 888501971800953XN EUDAMED
- EMDN Code
- W02060185 ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES 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
No
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™ Tip Cartridge Set 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 | 888501971800953XN | 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 0a817770-3226-40c9-9fbf-431e6c59adae 61 fields · synced Jun 18, 2026