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Strap4u Ice Hot Health Dent X2
EUDAMEDClass I (EU MDR)
Ref S4U_IHH_DX2Model STRAP4U ICE HOT HEALTH DENT X2
by Creation Xxi
Identity
- Trade Name
- STRAP4U ICE HOT HEALTH DENT X2 EUDAMED
- Device Name
- STRAP4U ICE HOT HEALTH DENT X2 EUDAMED
- Model / Reference
- STRAP4U ICE HOT HEALTH DENT X2 EUDAMEDS4U_IHH_DX2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700110954906 EUDAMED
- Basic UDI-DI
- 3770011095POD3Y 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 Hot Health Dent X2 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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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 | 3770011095POD3Y | Class I | Active |
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Manufacturer
- Manufacturer
- Creation Xxi
- EUDAMED SRN
- FR-MF-000012697
Sources (1)
- EUDAMED 9b0091f1-5b4e-4fd7-920f-6e184b9c96b3 61 fields · synced Jul 16, 2026