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Strap4u Ice Comfort
EUDAMEDClass I (EU MDR)
Ref S4U - ICModel STRAP4U ICE COMFORTRef S4U -PIC - DMPModel STRAP4U ICE COMFORT S
by Creation Xxi
Identity
- Trade Name
- STRAP4U ICE COMFORT EUDAMEDPOD STRAP4U ICE COMFORT D.M.P. EUDAMED
- Device Name
- STRAP4U ICE COMFORT EUDAMEDSTRAP4U ICE COMFORT S EUDAMED
- Model / Reference
- STRAP4U ICE COMFORT EUDAMEDS4U - IC EUDAMEDSTRAP4U ICE COMFORT S EUDAMEDS4U -PIC - DMP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700110950878 EUDAMED37700110953466 EUDAMED
- Basic UDI-DI
- 3770011095POD_02ZN EUDAMED3770011095POD_01ZL EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Strap4u Ice Comfort by Creation Xxi — 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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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
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- reusable cold hot gel pack for Ankle — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
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 | 3770011095POD_02ZN | Class I | Active |
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Manufacturer
- Manufacturer
- Creation Xxi
- EUDAMED SRN
- FR-MF-000012697
Sources (2)
- EUDAMED ede154a1-d6bc-4e52-9b57-e009c4c3d88a 61 fields · synced Jul 9, 2026
- EUDAMED 97230d4a-36fe-49b9-a864-a124870aa2a0 61 fields · synced May 17, 2026