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Zionic Aesthetic
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref M98AEModel ZIONIC AESTHETIC
Identity
- Trade Name
- ZIONIC AESTHETIC EUDAMEDFDA UDI
- Generic Name
- Medium-wave diathermy treatment system FDA UDI
- Device Name
- ZIONIC AESTHETIC EUDAMED
- Model / Reference
- ZIONIC AESTHETIC EUDAMEDFDA UDIM98AE EUDAMED
Identifiers
- Catalog Number
- M98AE FDA UDI
- Primary DI / UDI-DI
- 08436601290519 EUDAMEDFDA UDI
- Basic UDI-DI
- 843660129ZIONICTSH5 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 by Termosalud, S.L. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843660129ZIONICTSH5 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
Sources (2)
- EUDAMED 94e70595-8eb5-4179-b85f-77f9c99c18b0 61 fields · synced Jun 20, 2026
- FDA UDI 2de7d6d2-64ff-4854-b0aa-c471ac4a9b2b 34 fields · synced May 30, 2026