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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

MP.10.03.FN — Class I MDR by KINVENT Biomecanique

MD Atlas
KINVENT Biomecanique

EUDAMED last updated this device on Nov 27, 2023

MP.10.03.FN

3770011995KMyo95

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KINVENT Biomecanique
UDI-DI code: 03770011995875
Reference / catalog number: MP.10.03.FN

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Manufacturer information

Organization name: KINVENT Biomecanique
SRN: FR-MF-000031884
Manufacturer status: Active

Critical warnings

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

CW010
Do not use on patients with Silver allergies
CW020
The K-Myo and accessories are provided non-sterile and are not compatible with autoclave or other sterilization techniques. Do not autoclave.

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: not provided
UDI-DI code: 03770011995875
Basic UDI-DI: 3770011995KMyo95
Reference / catalog number: MP.10.03.FN
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: —
Additional information URL: https://physio.kinvent.com/product-page/k-myo/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12062401ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS

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

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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.