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Cool-X Cold Gel Roll-on 75 ml

EUDAMED

Class I (EU MDR)

Ref 1002/112R

Identity

Trade Name: Cool-X Cold Gel Roll-on 75 ml EUDAMED
Device Name: Cool-X Cold Gel Roll-on 75 ml EUDAMED
Model / Reference: 1002/112R EUDAMED

Identifiers

Primary DI / UDI-DI: D-FR10026Z EUDAMED
Basic UDI-DI: B-FR10026Z 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 Cold Gel Roll-on 75 ml 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

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Manufacturer

Manufacturer: Frescon Oy
EUDAMED SRN: FI-MF-000017377

Sources (1)

EUDAMED b86bba68-0a91-489d-8039-9c4cebaf1ca9 61 fields · synced Jul 16, 2026