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Strap4u Ice Hot Health Band S
EUDAMEDClass I (EU MDR)
Ref S4U_IHH_BDSModel STRAP4U ICE HOT HEALTH BAND S
by Creation Xxi
Identity
- Trade Name
- STRAP4U ICE HOT HEALTH BAND S EUDAMED
- Device Name
- STRAP4U ICE HOT HEALTH BAND S EUDAMED
- Model / Reference
- STRAP4U ICE HOT HEALTH BAND S EUDAMEDS4U_IHH_BDS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700110951936 EUDAMED
- Basic UDI-DI
- 3770011095POD_04ZS 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 Band S by Creation Xxi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
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- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- ACCU-THERM — Medline Industries, LP · Class I
- HotCold Pack reusable — Bevaplast B.V. · 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_04ZS | Class I | Active |
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Manufacturer
- Manufacturer
- Creation Xxi
- EUDAMED SRN
- FR-MF-000012697
Sources (1)
- EUDAMED d3f9cba7-a8cc-45c9-9cb6-22dda7f32734 61 fields · synced Jun 19, 2026