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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

QyScore — Class IIa MDR by Qynapse

MD Atlas
Qynapse

EUDAMED last updated this device on Feb 8, 2023

QyScore

3770016198QYMD62

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Qynapse
UDI-DI code: 03770016198004
Reference / catalog number: QyScore

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Manufacturer information

Organization name: Qynapse
SRN: FR-MF-000000499
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Oct 24, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770016198004
Basic UDI-DI: 3770016198QYMD62
Reference / catalog number: QyScore
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: —
Additional information URL: https://manuals.qynapse.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11030582RADIOLOGY 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

QyScoreB-03770016198004On 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.