Identity
- Trade Name
- ALTA Biochemistry Analyzer EUDAMED
- Device Name
- ALTA Biochemistry Analyzer EUDAMED
- Model / Reference
- ADX-230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G3202301 EUDAMED
- Basic UDI-DI
- ++G320ABA06QL EUDAMED
- Direct Marketing DI
- G3202301 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
New Device
No
EUDAMED
ALTA Biochemistry Analyzer by Athenese-Dx Private Limited — 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 | ++G320ABA06QL | Class A | Active |
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Manufacturer
- Manufacturer
- Athenese-Dx Private Limited
- EUDAMED SRN
- IN-MF-000031022
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 891815a6-3d6a-4013-867f-a0b3be3f7cc1 61 fields · synced Jul 26, 2026