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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

HEMABOX-POC-W102 - Windows7Embedded — Class I MDR

MD Atlas
Engenering Medical Application - EMA

EUDAMED last updated this device on Nov 15, 2021

HEMABOX-POC-W102 - Windows7Embedded

376034598HemaboxPX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Engenering Medical Application - EMA
UDI-DI code: 03760345980012
Reference / catalog number: HEMABOX-POC-W102 - Windows7Embedded

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Manufacturer information

Organization name: Engenering Medical Application - EMA
SRN: FR-MF-000008925
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW259
EUDAMED did not publish a description for this code.
CW258
EUDAMED did not publish a description for this code.
CW035
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	May 10, 2015	Still on market
Belgium	May 10, 2015	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03760345980012
Basic UDI-DI: 376034598HemaboxPX
Reference / catalog number: HEMABOX-POC-W102 - Windows7Embedded
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Hemabox est un interface Homme-Machine capable de s'interfacer avec de nombreux générateurs de dialyse afin de récupérer les données de séances des patients ainsi que la saisie des utilisateurs et transmettre les compte rendus de séances automatiquement à la base de gestion Hemadialyse.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12090282HAEMODIALYSIS INSTRUMENTS - SOFTWARE ACCESSORIES

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Hemabox - POC-W102 - Windows10E LSTB 2016376034598HemaboxPXOn 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.