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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

CYCL.FLO — Class I MDR by Itaka Way Med Srl

MD Atlas
Itaka Way Med Srl

EUDAMED last updated this device on Mar 5, 2025

CYCL.FLO

805903737AccessCyclopsP3

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Itaka Way Med Srl
UDI-DI code: 08059037370046
Reference / catalog number: CYCL.FLO

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View device family (Basic UDI)

Manufacturer information

Organization name: Itaka Way Med Srl
SRN: IT-MF-000030937
Manufacturer status: Active

Related devices

CYCL.PNT805903737AccessCyclopsP3On the market CYCL.F1805903737AccessCyclopsP3On the market CYCL.F1S805903737AccessCyclopsP3On the market CYCL.SUP805903737AccessCyclopsP3On the market CYCHW5805903737CyclopsCl12KOn 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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08059037370046
Basic UDI-DI: 805903737AccessCyclopsP3
Reference / catalog number: CYCL.FLO
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: Accessorio Mandyfork Overlip
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)08059037370046

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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.

Z12062503KINEMATIC OPTOELECTRONIC MOTION CAPTURE ANALYSIS SYSTEMS USING PASSIVE MARKERS

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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