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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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ECU 100 — 1 UDI-DI variant, MDD (BrainCool AB)

MD Atlas
BrainCool AB

Data from EUDAMED, last updated May 31, 2026

ECU 100

B-07350135110130

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: BrainCool AB

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Device characteristics

Active device

Legacy certificates

Certificate number: G10913680002
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: May 6, 2024

Certificate number: CL0913680005
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: Dec 31, 2028

Certificate number: Q50913680003
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: Sep 14, 2027

Identity & classification

Basic UDI-DI: B-07350135110130
Device name: ECU 100
Device model: BC10-000
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: Jan 19, 2026

Manufacturer & authorised representative

Manufacturer

Name: BrainCool AB
SRN: SE-MF-000005547
Country: Sweden
Email: info@braincool.se

Variants by status

UDI-DI variants

1 UDI-DI variant

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Export results

Applied filters

basicUdiUlid01KFB9CX7J67VF4CAQX1QF0SKE

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

BrainCool System07350135110130