Identity
- Trade Name
- ELEVACE EUDAMED
- Device Name
- GHIACCIO ISTANTANEO MONOUSO - DISPOSABLE COLD PACK EUDAMED
- Model / Reference
- SF2454KLSPORT EUDAMED
Identifiers
- Primary DI / UDI-DI
- G066SF2454KLSPORT0 EUDAMED
- Basic UDI-DI
- ++G066SFDIS6Z EUDAMED
- Direct Marketing DI
- G066SF2454KLSPORT0 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Elevace by Dispotech srl — Class IIa — 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 | ++G066SFDIS6Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dispotech srl
- EUDAMED SRN
- IT-MF-000010735
Sources (1)
- EUDAMED 07dcb040-b695-4be7-8601-5db239410f7c 61 fields · synced Jul 19, 2026