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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

FITO FLEX ELBOW — Class I MDR by PHYTO PERFORMANCE…

MD Atlas
PHYTO PERFORMANCE ITALIA SRL

EUDAMED last updated this device on May 20, 2026

FITO FLEX ELBOW

80312550009K4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PHYTO PERFORMANCE ITALIA SRL
UDI-DI code: 08031255011468
Reference / catalog number: P.203

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View device family (Basic UDI)

Manufacturer information

Organization name: PHYTO PERFORMANCE ITALIA SRL
SRN: IT-MF-000008118
Manufacturer status: Active

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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.

Critical warnings

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

CW999
serious pathologies which may require a specific medical treatment, known allergies. In case of circulatory problems use it under medical supervision. Do not use it while sleeping.

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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: FITO FLEX ELBOW
UDI-DI code: 08031255011468
Basic UDI-DI: 80312550009K4
Reference / catalog number: P.203
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: Protective elastic bandages for supporting the body joints while at rest and during the sport activity. They are very resistant and lasting. Available for: ankle, knee, wrist, elbow. One size fits all. Adjustable with Velcro for a comfortable fit.
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

EMDN nomenclature code(s)

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

Y090612ARM AND ELBOW PROTECTIONS

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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