Identity
- Trade Name
- BSmart® EUDAMED
- Device Name
- Injection pressure monitoring device EUDAMED
- Model / Reference
- 4894000-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18053676296641 EUDAMED
- Basic UDI-DI
- 805367629TD012BSmrtTS EUDAMED
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BSmart® by HMC Premedical S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805367629TD012BSmrtTS | Class I | Active |
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Manufacturer
- Manufacturer
- Hmc Premedical S.p.a.
- EUDAMED SRN
- IT-MF-000029438
Sources (1)
- EUDAMED 7414fa78-630f-40fa-95a1-976255ce2909 61 fields · synced Jun 19, 2026