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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

BrainCool System — Class IIb MDD by BrainCool AB

MD Atlas
BrainCool AB

EUDAMED last updated this device on Jan 26, 2026

BrainCool System

B-07350135110130

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: BrainCool AB
UDI-DI code: 07350135110130
Reference / catalog number: BC10-000

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View device family (Basic UDI)

Manufacturer information

Organization name: BrainCool AB
SRN: SE-MF-000005547
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 26, 2017	Dec 31, 2028
Sweden	Apr 28, 2017	Dec 31, 2028

Device identification

Trade name: BrainCool System
UDI-DI code: 07350135110130
Basic UDI-DI: B-07350135110130
Reference / catalog number: BC10-000
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The BrainCool System (ECU 100) is intended for monitoring and controlling patient temperature.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 73 MU29
105.2 MU10
4.5 MU02
50.5 MU10
61 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350135110130

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

BC10-00117350135110026SOn the market BC10-00137350135110026SOn the market BC10-00127350135110026SOn the market BC10-00107350135110026SOn the market BC10-00187350135110026SOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.