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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

Tricycle 20/20" — Class I MDR by ORTOSANA, PRODAJA IN…

MD Atlas
ORTOSANA, PRODAJA IN SERVIS REHABILITACIJSKIH PRIPOMOČKOV D.O.O.

EUDAMED last updated this device on May 27, 2026

Tricycle 20/20"

383008297TRK1226GF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTOSANA, PRODAJA IN SERVIS REHABILITACIJSKIH PRIPOMOČKOV D.O.O.
UDI-DI code: 03830082970055
Reference / catalog number: 20/20" /110/150

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View device family (Basic UDI)

Manufacturer information

Organization name: ORTOSANA, PRODAJA IN SERVIS REHABILITACIJSKIH PRIPOMOČKOV D.O.O.
SRN: SI-MF-000051123
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.

CW011
Use of the device is prohibited or requires strict medical consultation in cases of: severe and uncontrolled epilepsy, severe cognitive impairment (where the user cannot follow instructions), unstable fractures, severe osteoporosis, and pronounced balance disorders that the device cannot safely compensate for.

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Market distribution

Primary placement in Slovenia; available across 1 country total.

Country	On market since	Until
SloveniaPrimary placement	Dec 15, 2003	Still on market

Device identification

Trade name: Tricycle 20/20"
UDI-DI code: 03830082970055
Basic UDI-DI: 383008297TRK1226GF
Reference / catalog number: 20/20" /110/150
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: The 20/20" tricycle is designed to improve the mobility of persons with physical or motor impairments.
Additional information URL: https://ortosana.si/product/trokolo/
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)03830082970055

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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.

Y121801BICYCLES

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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