Identity
- Trade Name
- ENEKA PRO EUDAMED
- Device Name
- ENEKA PRO EUDAMED
- Model / Reference
- ENEKA PRO EUDAMEDM91M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436601290229 EUDAMED
- Basic UDI-DI
- B-08436601290229 EUDAMED
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Eneka Pro by Termosalud, S.L. — Class IIb — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223680 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08436601290229 | 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
Sources (2)
- EUDAMED e2964f5e-3517-4059-b07f-cae8100580f8 61 fields · synced Jul 12, 2026
- FDA 510(k) K223680 1 fields · synced May 18, 2026