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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-SW-MEDICOAMICOPORTAL — Class I MDR by Khymeia S.r.l.

MD Atlas
Khymeia S.r.l.

EUDAMED last updated this device on May 20, 2026

KHY-SW-MEDICOAMICOPORTAL

805071490MEDICOAMICOPRTR8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Khymeia S.r.l.
UDI-DI code: 08050714900990
Reference / catalog number: KHY-SW-MEDICOAMICOPORTAL

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View device family (Basic UDI)

Manufacturer information

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

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Critical warnings

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

CW999
The application must be used by healthcare personnel or by personnel authorized by the facility, in accordance with the procedures described in this manual. The clinical operator must use the application while observing appropriate break periods during professional activity and in compliance with the procedures established by the relevant facility.

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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: 08050714900990
Basic UDI-DI: 805071490MEDICOAMICOPRTR8
Reference / catalog number: KHY-SW-MEDICOAMICOPORTAL
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)08050714900990

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EMDN nomenclature code(s)

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

Z12069092VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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.