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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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UNISPLINT fixation splint — 3 UDI-DI variants, MDR (BIOSTER, a.s.)

MD Atlas
BIOSTER, a.s.

Data from EUDAMED, last updated May 23, 2026

UNISPLINT fixation splint

85903170001SF

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: BIOSTER, a.s.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 85903170001SF
Device name: UNISPLINT fixation splint
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Apr 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: BIOSTER, a.s.
SRN: CZ-MF-000011615
Country: Czechia
Email: bioster@bioster.cz
Phone: +420 549 429 111

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01KQA26B7K9TDRAH6BWVE8JYVR

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

UNISPLINT - fixation splint18590317150004
UNISPLINT - fixation splint18590317150073
UNISPLINT - fixation splint18590317150028