Identity
- Trade Name
- IGLOO ATTELLE CHAUSSON CHEVILLE EUDAMED
- Device Name
- IGLOO Dispositif de Cryothérapie Compressive EUDAMED
- Model / Reference
- IGLOO EUDAMEDIGCH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615570000458 EUDAMED
- Basic UDI-DI
- 3615570IGLOOUS 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
Igloo Attelle Chausson Cheville by Implants Service Orthopedie — 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 | 3615570IGLOOUS | Class I | Active |
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Manufacturer
- Manufacturer
- Implants Service Orthopedie
- EUDAMED SRN
- FR-MF-000000297
Sources (1)
- EUDAMED 3542b26f-9405-4a5e-89c6-8bcab31e00d0 61 fields · synced Jul 29, 2026