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PolarCool AB

Active in EUDAMED

Swedenfrom SRN EUDAMED SRN SE-MF-000002894

Devices
3
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

Catalogue3

Newest first, rows 1-3 of 3

  • PolarCap System Ref PC10-001

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa
  • PolarCap HeadCap Ref PC10-002

    Active Regimes: CE MDR Registry: EUDAMED Class:I
  • SmallCool Ref PC10-003

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Company details

EUDAMED SRN
SE-MF-000002894
EU VAT number
se559095678401
EUDAMED status
Active
EUDAMED registered name
PolarCool AB
Registered address
Scheelevägen 2, Medicon Village, 22381, Lund, Sweden
PRRC contact
Kim Isaksson(public in EUDAMED)

From the company website

Read 18 Sep 2026

PolarCap® is a portable cooling system that lowers brain temperature after sports concussions, helping prevent cognitive impairments and reducing recovery time.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does PolarCool AB have in the registry?

The registry currently lists 3 devices for PolarCool AB. Devices recorded under merged duplicate company entries are counted once.

Which registries list PolarCool AB's devices?

Among its 3 most recently registered devices, PolarCool AB has devices listed in EUDAMED (3 devices).

What risk classes do PolarCool AB's devices fall under?

Among its 3 most recently registered devices, the classes recorded for PolarCool AB's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from PolarCool AB in the registry?

The most recently registered devices listed for PolarCool AB include PolarCap System, PolarCap HeadCap and SmallCool.

Generated automatically from registry data and not verified by a human reviewer.