Identity
- Trade Name
- Alpha EUDAMED
- Device Name
- Alpha EUDAMED
- Model / Reference
- Alpha 8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060210400002 EUDAMED
- Basic UDI-DI
- B-05060210400002 EUDAMED
- EMDN Code
- W02079082 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Special Device Type
- -1202 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
Alpha by Logical Medical Systems Limited — Class IVD Annex II List B — 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-05060210400002 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Logical Medical Systems Limited
- EUDAMED SRN
- GB-MF-000029109
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 1c32ae0f-6ac6-4de3-9cc4-a1fee5ed3199 61 fields · synced Jun 19, 2026