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Cryoflex Spalle - Terapia Caldo Freddo
EUDAMEDClass I (EU MDR)
Ref P200.13/SPALLA
Identity
- Trade Name
- CRYOFLEX SPALLE - TERAPIA CALDO FREDDO EUDAMED
- Device Name
- CUSCINETTO GEL RIUTILIZZABILE EUDAMED
- Model / Reference
- P200.13/SPALLA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08031255034627 EUDAMED
- Basic UDI-DI
- 80312550003JQ EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I 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
Cryoflex Spalle - Terapia Caldo Freddo by Phyto Performance Italia Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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Manufacturer's product page: Freddo / Caldo
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 | 80312550003JQ | Class I | Active |
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Manufacturer
- Manufacturer
- Phyto Performance Italia Srl
- EUDAMED SRN
- IT-MF-000008118
Sources (1)
- EUDAMED 62fa1585-ed78-44d2-b57d-1f04c9eaf7a7 61 fields · synced Jul 10, 2026