Identity
- Trade Name
- FREEZE/GHIACCIO 200 ML SPRAY EUDAMED
- Device Name
- Ghiaccio Spray, Ice Spray EUDAMED
- Model / Reference
- FPxxxxxx EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08011400002657 EUDAMED
- Basic UDI-DI
- 801140000ICE6A EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Category: Hot/cold therapy pack, reusable
Freeze/Ghiaccio 200 Ml Spray by Volcke Aerosol Italy S.r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 801140000ICE6A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Volcke Aerosol Italy S.r.l.
- EUDAMED SRN
- IT-MF-000029086
Sources (1)
- EUDAMED 375b07c0-d935-426a-9e46-6fa2a3e28be2 61 fields · synced Jul 21, 2026