← Back to catalogue
Zionic Aesthetic Hp
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref A463AEModel ZIONIC AESTHETIC HP510(k) K230659
Identity
- Trade Name
- ZIONIC AESTHETIC HP EUDAMEDZIONIC AESTHETIC FDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- ZIONIC AESTHETIC HP EUDAMED
- Model / Reference
- ZIONIC AESTHETIC HP EUDAMEDFDA UDIA463AE EUDAMED
Identifiers
- Catalog Number
- A463AE FDA UDI
- Primary DI / UDI-DI
- 08436601290526 EUDAMEDFDA UDI
- Basic UDI-DI
- 843660129ZIONICAEHPR6 EUDAMED
- 510(k) Number
- K230659 FDA UDI
- FDA Product Code
- PBX FDA UDI
- EMDN Code
- Z12040203 DERMAL REGENERATION EQUIPMENT EUDAMED
- GMDN Term
- Medium-wave diathermy treatment system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zionic Aesthetic Hp by Termosalud, S.L. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230659 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 843660129ZIONICAEHPR6 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
- FDA Applicant
- Termosalud
Sources (3)
- EUDAMED 6ee82f66-8af6-4671-85a0-2b81eafd48dc 85 fields · synced Jun 18, 2026
- FDA UDI e5140319-e080-42df-9c20-3ee2c6c38474 34 fields · synced May 30, 2026
- FDA 510(k) K230659 1 fields · synced May 18, 2026