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Organization name
UDI-DI code
Reference / catalog number

Bone file, 20 mm, 295 mm — Class I MDR by SUBAN Kéziműszer…

MD Atlas
SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on May 26, 2026

Bone file, 20 mm, 295 mm

5996660RaspatoriumokB7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság
UDI-DI code: 05996660052587
Reference / catalog number: RL-424-28

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Manufacturer information

Organization name: SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság
SRN: HU-MF-000006381
Manufacturer status: Active

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Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: Bone file, 20 mm, 295 mm
UDI-DI code: 05996660052587
Basic UDI-DI: 5996660RaspatoriumokB7
Reference / catalog number: RL-424-28
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://www.suban-instruments.hu/?lang=en
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L091202ORTHOPAEDIC SURGERY FILES, REUSABLE

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

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Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

25 0316 QA/NBIssued
Quality assuranceNotified body: 1023Expiry: Aug 14, 2030