Identity
- Trade Name
- Refenum Ice 50 ml EUDAMED
- Device Name
- Refenum Ice EUDAMED
- Model / Reference
- 350138 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430030150101 EUDAMED
- Basic UDI-DI
- B-06430030150101 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Refenum Ice 50 ml by Galena Pharma 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 Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06430030150101 | Class I | Active |
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Manufacturer
- Manufacturer
- Galena Pharma Oy
- EUDAMED SRN
- FI-MF-000000588
Sources (1)
- EUDAMED e60599d8-73f4-421d-99c5-4578a5795d6f 61 fields · synced Jul 12, 2026