Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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

8105129 — Class I MDR by OTOS Ortopedska tehnika…

MD Atlas
OTOS Ortopedska tehnika d.o.o.

EUDAMED last updated this device on Oct 3, 2024

8105129

38588939881051285N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: OTOS Ortopedska tehnika d.o.o.
UDI-DI code: 03858893980384
Reference / catalog number: 8105129

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?

Manufacturer information

Organization name: OTOS Ortopedska tehnika d.o.o.
SRN: HR-MF-000040944
Manufacturer status: Active

Related devices

509911538588939850991157COn the market 509911638588939850991157COn the market 509911738588939850991157COn the market 509911838588939850991157COn the market 509911938588939850991157COn 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

2 warnings recorded — scroll inside the panel to see all entries.

CW999
KONTRAINDIKACIJE: Značajniji deformiteti stopala; Diabetes Mellitus; Bavljenje sportom; Rane na mjestu primjene; Ozljeda stopala
CW011
Upozorenje: Kod stalne uporabe proizvoda može doći do iritacije osjetljive kože. Upozorenje: Proizvod je namijenjen višekratnoj uporabi od strane jednog korisnika. Upozorenje: Molimo Vas da ne koristite proizvod ukoliko je oštećen. Upozorenje: Molimo Vas da prije uporabe pažljivo i temeljito pročitate upute za uporabu. Upute za uporabu sačuvajte radi buduće primjene. Upozorenje: Molimo Vas da proizvod koristite samo u dodiru s neoštećenom i/ili zaštićenom kožom tijela.

Market distribution

Primary placement in Croatia; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03858893980384
Basic UDI-DI: 38588939881051285N
Reference / catalog number: 8105129
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: https://otos.hr/upload/2024/08/ortopedski_ulosci_unirelax_upt_web_202408001red_66c352a4de29e.pdf
Clinical sizes: Veličina cipele 29

EMDN nomenclature code(s)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification