Identity
- Trade Name
- BrainCool System EUDAMED
- Device Name
- ECU 100 EUDAMED
- Model / Reference
- BC10-000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350135110130 EUDAMED
- Basic UDI-DI
- B-07350135110130 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
BrainCool System by BrainCool AB — Class IIb — 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-07350135110130 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BrainCool AB
- EUDAMED SRN
- SE-MF-000005547
Sources (1)
- EUDAMED 7aefe4b8-06bc-403d-a0dc-0d2fc9d5d876 61 fields · synced Jul 9, 2026