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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

BX-100_AAE — Class IIa MDR by BiOSENCY

MD Atlas
BiOSENCY

EUDAMED last updated this device on Jun 3, 2024

BX-100_AAE

3770024064BC4H-EXA-ICAP

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BiOSENCY
UDI-DI code: 03770024064070
Reference / catalog number: BX-100_AAE

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Manufacturer information

Organization name: BiOSENCY
SRN: FR-MF-000007771
Manufacturer status: Active

Related devices

Bora Band3770024064boraC8On the market Bora Connect3770024064connectTWOn the market Network Gateway device Firmware3770024064NGDFW6On the market KS-100_A003770024064BCpatientKTOn the market BX-100_AAA3770024064BC4HRMOn 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.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	May 27, 2024	Jun 11, 2028

Device identification

Trade name: not provided
UDI-DI code: 03770024064070
Basic UDI-DI: 3770024064BC4H-EXA-ICAP
Reference / catalog number: BX-100_AAE
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Bora connect for study – EXA-IC: is an accessory of Bora Connect and Bora band. It is a mobile application used to ensure communication between the two medical devices, and to allow patients to answer surveys in the framework of a clinical study. Bora connect for study is intended to be used in combination with Bora band and Bora Connect.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

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Software identification