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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

KS-100_A00 — Class IIa MDR by BiOSENCY

MD Atlas
BiOSENCY

EUDAMED last updated this device on Jul 10, 2023

KS-100_A00

3770024064BCpatientKT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BiOSENCY
UDI-DI code: 03770024064032
Reference / catalog number: KS-100_A00

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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 BX-100_AAA3770024064BC4HRMOn the market BX-100_AAE3770024064BC4H-EXA-ICAPOn 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	Jun 12, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770024064032
Basic UDI-DI: 3770024064BCpatientKT
Reference / catalog number: KS-100_A00
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 patient: 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 consult their data and to answer surveys. Bora connect for patient 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification