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Pod Strap4u Ice Hot Health Dent
EUDAMEDClass I (EU MDR)
Ref S4U -PIC - DModel STRAP4U ICE COMFORT SRef POD S4U_IHHModel STRAP4U ICE HOT HEALTH BAND SRef POD S4U_IHH_DModel STRAP4U ICE HOT HEALTH DENT X2
by Creation Xxi
Identity
- Trade Name
- POD STRAP4U ICE HOT HEALTH DENT EUDAMEDPOD STRAP4U ICE HOT HEALTH EUDAMED
- Device Name
- STRAP4U ICE COMFORT S EUDAMEDSTRAP4U ICE HOT HEALTH BAND S EUDAMEDSTRAP4U ICE HOT HEALTH DENT X2 EUDAMED
- Model / Reference
- STRAP4U ICE COMFORT S EUDAMEDS4U -PIC - D EUDAMEDSTRAP4U ICE HOT HEALTH BAND S EUDAMEDPOD S4U_IHH EUDAMEDSTRAP4U ICE HOT HEALTH DENT X2 EUDAMEDPOD S4U_IHH_D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700110951554 EUDAMED37700110951486 EUDAMED37700110955446 EUDAMED
- Basic UDI-DI
- 3770011095POD_01ZL EUDAMED3770011095POD_04ZS EUDAMED3770011095POD3Y 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
Pod Strap4u Ice Hot Health Dent 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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- 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_01ZL | Class I | Active |
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Manufacturer
- Manufacturer
- Creation Xxi
- EUDAMED SRN
- FR-MF-000012697
Sources (3)
- EUDAMED d97e7dbd-e04e-4063-bc9d-c7dbba43808f 61 fields · synced Jul 29, 2026
- EUDAMED 2d43fbf3-ed8c-4c1f-bd77-4e1710f3c4f5 61 fields · synced May 18, 2026
- EUDAMED ac056592-644a-4041-b27c-bfc8b5455edf 61 fields · synced May 18, 2026