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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

UNISPLINT - fixation splint — Class I MDR by BIOSTER, a.s.

MD Atlas
BIOSTER, a.s.

EUDAMED last updated this device on Apr 28, 2026

UNISPLINT - fixation splint

85903170001SF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSTER, a.s.
UDI-DI code: 18590317150073
Reference / catalog number: 15007

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Manufacturer information

Organization name: BIOSTER, a.s.
SRN: CZ-MF-000011615
Manufacturer status: Active

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Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: UNISPLINT - fixation splint
UDI-DI code: 18590317150073
Basic UDI-DI: 85903170001SF
Reference / catalog number: 15007
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: No additional information URL provided by the manufacturer.
Clinical sizes: 50 x 800 mm

EMDN nomenclature code(s)

M03050202SYNTHETIC CAST BANDAGES AND SPLINTS

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

Certificates

Certificate health across this manufacturer's portfolio.

24 0145 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Apr 28, 2029
24 0146 TD/NBIssued
Technical documentationNotified body: 1023Expiry: Apr 28, 2029