Identity
- Trade Name
- Kryo ice EUDAMED
- Model / Reference
- KRYO ICE EUDAMED2211 EUDAMED3819 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055510560249 EUDAMED08055510560232 EUDAMED
- Basic UDI-DI
- 805551056kryo_ice9H 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
Category: Hot/cold therapy pack, reusable
Kryo ice by Kaltek S.r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 | 805551056kryo_ice9H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kaltek S.r.l.
- EUDAMED SRN
- IT-MF-000019573
Sources (2)
- EUDAMED 2ac073f2-a270-4eee-a20c-57450c9e36e3 61 fields · synced Jul 21, 2026
- EUDAMED aaba7e4b-934c-46fd-bd5b-996090374d20 61 fields · synced May 17, 2026