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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

KHY-K-SENSOR — Class I MDR by Khymeia S.r.l.

MD Atlas
Khymeia S.r.l.

EUDAMED last updated this device on May 20, 2026

KHY-K-SENSOR

805071490KSENSORPM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Khymeia S.r.l.
UDI-DI code: 08050714901003
Reference / catalog number: KHY-K-SENSOR

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Manufacturer information

Organization name: Khymeia S.r.l.
SRN: IT-MF-000035617
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
Use only cables, power adapters, and accessories supplied or approved by Khymeia. The K-Sensor device is powered by an internal rechargeable battery. Connection to the mains power supply is permitted exclusively for battery charging. Do not use the device while charging. Before performing exercises, disconnect the sensor from the charging cable. Do not charge the device in the presence of humidity, wet surfaces, water splashes, liquids, or steam. Do not use or store the device near flammable substances, products, or liquids. Do not use or place the device in environments where the temperature exceeds 40 °C, the relative humidity exceeds 75%, or the atmospheric pressure exceeds 106 kPa. The operating temperature must be between 0 °C and +40 °C; the relative humidity must be between 30% and 75%; the atmospheric pressure must be between 70.0 kPa and 106.0 kPa. In the event of damage to the sensor, charging cable, or power adapter, discontinue use and contact Khymeia or the reference facility. Use only with compatible Khymeia medical software/applications.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08050714901003
Basic UDI-DI: 805071490KSENSORPM
Reference / catalog number: KHY-K-SENSOR
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08050714901003

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12069080VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - HARDWARE 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

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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.