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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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FastStroke — 4 UDI-DI variants, MDR (GE Medical Systems SCS)

MD Atlas
GE Medical Systems SCS

Data from EUDAMED, last updated May 19, 2026

FastStroke

8406821BUG00068HE

4 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: GE Medical Systems SCS

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Device characteristics

Active deviceMeasuring function

Identity & classification

Basic UDI-DI: 8406821BUG00068HE
Device name: FastStroke
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Special device type: refdata.special-mdr-device-type.software
Version date: May 19, 2022

Manufacturer & authorised representative

Manufacturer

Name: GE Medical Systems SCS
SRN: FR-MF-000000687
Country: France
Email: eudamed@gehealthcare.com

Variants by status

UDI-DI variants

4 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G2CAXQEAZA6MQJQ3QBCKEX2E

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

597626200198953041444
597097800195278923622
585435400195278301000
593473600195278688309