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Organization name
UDI-DI code
Reference / catalog number

8105136 — Class I MDR by OTOS Ortopedska tehnika…

MD Atlas
OTOS Ortopedska tehnika d.o.o.

EUDAMED last updated this device on Oct 3, 2024

8105136

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: 03858893980452
Reference / catalog number: 8105136

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Manufacturer information

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

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: 03858893980452
Basic UDI-DI: 38588939881051285N
Reference / catalog number: 8105136
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 36

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

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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.