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PolarCap HeadCap
EUDAMEDClass I (EU MDR)
Ref PC10-002Model PolarCap HeadCap
by BrainCool AB
Identity
- Trade Name
- PolarCap HeadCap EUDAMED
- Device Name
- PolarCap HeadCap EUDAMED
- Model / Reference
- PolarCap HeadCap EUDAMEDPC10-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350135110352 EUDAMED
- Basic UDI-DI
- 73501351100876 EUDAMED
- Direct Marketing DI
- 07350135110352 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
PolarCap HeadCap by BrainCool AB — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73501351100876 | Class I | Active |
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Manufacturer
- Manufacturer
- BrainCool AB
- EUDAMED SRN
- SE-MF-000005547
Sources (1)
- EUDAMED 477173f5-44be-4e8e-b498-37a7e46965bd 61 fields · synced Jun 19, 2026