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Cool-X Kylmägeeli
EUDAMEDClass I (EU MDR)
Ref 1003/151Model #1002/ 75ml; #1003/ 150ml; #1004/ 500ml; #1009/ 50ml; #1010/ 7ml; #1013/ 100 ml
by Frescon Oy
Identity
- Trade Name
- Cool-X Kylmägeeli EUDAMED
- Device Name
- Cool-X Cold Gel EUDAMED
- Model / Reference
- #1002/ 75ml; #1003/ 150ml; #1004/ 500ml; #1009/ 50ml; #1010/ 7ml; #1013/ 100 ml EUDAMED1003/151 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-10039C EUDAMED
- Basic UDI-DI
- B-10039C EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Cool-X Kylmägeeli by Frescon 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-10039C | Class I | Active |
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Manufacturer
- Manufacturer
- Frescon Oy
- EUDAMED SRN
- FI-MF-000017377
Sources (1)
- EUDAMED a630f3f1-2e76-4888-8dee-f64f4f088158 61 fields · synced Jun 18, 2026