Identity
- Trade Name
- Epi-Bion Cool Gel EUDAMED
- Device Name
- Epi-Bion Cool Gel (Gre) EUDAMEDEpi-Bion Cool Gel (Eng) EUDAMED
- Model / Reference
- EB20132 EUDAMEDEB20231 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06417150020132 EUDAMED06417150020231 EUDAMED
- Basic UDI-DI
- B-06417150020132 EUDAMEDB-06417150020231 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Epi-Bion Cool Gel by Sim Finland Oy — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06417150020132 | Class I | No Longer Active |
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Manufacturer
- Manufacturer
- Sim Finland Oy
- EUDAMED SRN
- FI-MF-000016788
Sources (2)
- EUDAMED 8f00fde9-f288-4691-9039-1ed417018f52 61 fields · synced Jul 29, 2026
- EUDAMED f4c912ae-8b19-4032-a038-45109b9e609d 61 fields · synced May 18, 2026