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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

QTT Solution — Class I MDR by MedClinik SAS

MD Atlas
MedClinik SAS

EUDAMED last updated this device on Aug 31, 2022

QTT Solution

3770021452AFL1111XSD000FB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MedClinik SAS
UDI-DI code: 03770021452023
Reference / catalog number: M0213

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Manufacturer information

Organization name: MedClinik SAS
SRN: FR-MF-000009359
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: QTT Solution
UDI-DI code: 03770021452023
Basic UDI-DI: 3770021452AFL1111XSD000FB
Reference / catalog number: M0213
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: The QTT solution is a software suite (web app + mobile app) that is intended to : - calculate the size of the treatment area of a patient with peripheral neuropathic pain treated with Qutenza®. - identify and to mark by the HCP during the application procedure of the patch. - record the marked area to be treated, monitor the change of the treatment area size, and - support treatment follow-up as it provides the calculation and comparison between current and previous treatment areas.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z129082VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - 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

This device is not currently linked to any other device.

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.