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Symmed Elite Aesthetic
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref M85AEModel SYMMED ELITE AESTHETIC
Identity
- Trade Name
- SYMMED ELITE AESTHETIC EUDAMED
- Device Name
- SYMMED ELITE AESTHETIC EUDAMED
- Model / Reference
- SYMMED ELITE AESTHETIC EUDAMEDM85AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436601290359 EUDAMED
- Basic UDI-DI
- 843660129SYMMEDTSKL EUDAMED
- EMDN Code
- Z12040203 DERMAL REGENERATION 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
Symmed Elite Aesthetic by Termosalud, S.L. — Class IIb — FDA_510K, MDR — listed in EUDAMED, 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 | K230412 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 843660129SYMMEDTSKL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Termosalud, S.L.
- EUDAMED SRN
- ES-MF-000019177
Sources (2)
- EUDAMED fe05be0c-eeef-45db-a465-eea135dfdcfd 61 fields · synced Jul 15, 2026
- FDA 510(k) K230412 1 fields · synced May 18, 2026