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Cool-X Cold Spray
EUDAMEDClass IIa (EU MDR)
Ref 1021Model Cold Spray
by Frescon Oy
Identity
- Trade Name
- Cool-X Cold Spray EUDAMED
- Device Name
- Cool-X Cold Spray EUDAMED
- Model / Reference
- Cold Spray EUDAMED1021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-10219E EUDAMED
- Basic UDI-DI
- B-10219E EUDAMED
- EMDN Code
- V0999 FLUIDS/GASES FOR CLINICAL/THERAPEUTICAL USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Cool-X Cold Spray by Frescon Oy — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-10219E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Frescon Oy
- EUDAMED SRN
- FI-MF-000017377
Sources (1)
- EUDAMED 636f9fcf-b29b-410b-bb26-f3226513b76e 61 fields · synced Jul 10, 2026