Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Tricycle 16" — 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 16"

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: 03830082970031
Reference / catalog number: 16"/110

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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

Related devices

Standing frame J150383008297ST12157DOn the market Standing frames J120383008297ST12157DOn the market Therapeutic bicycle 24"383008297TK24265DOn the market Therapeutic bicycle 26"383008297TK24265DOn the market Tricycle 20/16"383008297TRK1226GFOn the market

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.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

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 16"
UDI-DI code: 03830082970031
Basic UDI-DI: 383008297TRK1226GF
Reference / catalog number: 16"/110
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 16" 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)03830082970031

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

UDI-PI DataMatrix

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

Sign in to generate the UDI-PI DataMatrix

Create a free account, then generate the compliant UDI-PI carrier for this device.

Email

Password

No account yet?

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

Become a partner of MD Atlas

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.