Identity
- Trade Name
- BIA101 BIVA PRO EUDAMED
- Device Name
- Body Impedance Analyzers EUDAMEDBody Impedance Analyzer EUDAMED
- Model / Reference
- 00BSE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80515774700880 EUDAMED
- Basic UDI-DI
- 805157747BIAK7 EUDAMEDB-80515774700880 EUDAMED
- Direct Marketing DI
- 80515774700880 EUDAMED
- EMDN Code
- Z12099001 BODY IMPEDANCE ANALYSERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bia101 Biva Pro by Akern Srl — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805157747BIAK7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 805157747BIAK7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Akern Srl
- EUDAMED SRN
- IT-MF-000013092
Sources (2)
- EUDAMED 68348379-e2bf-4d06-a16d-c0ffb2f6d8b2 61 fields · synced Jul 15, 2026
- EUDAMED c43f1737-eb8e-4acf-a94a-c2bffe8878d7 61 fields · synced May 17, 2026