Identity
- Device Name
- HP-V EUDAMED
- Model / Reference
- HP-V EUDAMEDA2181AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436601290373 EUDAMED
- Basic UDI-DI
- 843660129SWVTN4 EUDAMED
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hp-V by Termosalud, S.L. — Class IIb — 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 | 843660129SWVTN4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
Sources (1)
- EUDAMED 8259a289-d286-4579-81fe-4b5566a860a5 61 fields · synced Sep 30, 2026