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IceBand Foot/Ankle
EUDAMEDClass I (EU MDR)
Ref IB4008_WModel Orthopedic Cold Bandage
Identity
- Trade Name
- IceBand Foot/Ankle EUDAMED
- Model / Reference
- Orthopedic Cold Bandage EUDAMEDIB4008_W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350049944081 EUDAMED
- Basic UDI-DI
- 735004994ICEBAND400042 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
IceBand Foot/Ankle by I & B Medical AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hot/cold therapy pack, reusable.
- Future Generation Medical — Global International L. L. C. · Class I
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- HOT/COLD THERAPEUTIC PACK FOR KNEE — Wuhan Pakcare Bio‐technology Co.,Ltd. · Class I
- hot cold pack — Anhui Kamt Ice Pack Co.,Ltd. · Class I
- HotCold Pack reusable — Bevaplast B.V. · Class I
- 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 | 735004994ICEBAND400042 | Class I | Active |
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Manufacturer
- Manufacturer
- I & B Medical AB
- EUDAMED SRN
- SE-MF-000053424
Sources (1)
- EUDAMED 00526cf6-cc9a-4752-8438-b107a7fa3b36 61 fields · synced Jun 18, 2026