Identity
- Trade Name
- CONFIDERM EUDAMEDConfiderm - Benda autoaderente EUDAMED
- Device Name
- INSTANT ICE PACK EUDAMEDADHESIVE ELASTIC COMPRESSION BANDAGE EUDAMED
- Model / Reference
- GIS600797 EUDAMEDBEC239565 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08051739600797 EUDAMED08050713239565 EUDAMED
- Basic UDI-DI
- B-08051739600797 EUDAMED8017990BECEL EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMEDM0304010202 ELASTIC COMPRESSION BANDAGES, COHESIVE, MEDIUM EXTENSIBILITY (70-140%) EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Italy 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
Confiderm by Eurosirel Spa — Class IIa — MDR, MDD — 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 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
- ACCU-THERM — Medline Industries, LP · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08051739600797 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08051739600797 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (2)
- EUDAMED 6df75684-fc40-4d17-bfce-465854761a4a 61 fields · synced Jul 29, 2026
- EUDAMED b072ed82-a7a1-40fe-bdf3-301c90b8d068 61 fields · synced May 17, 2026