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Organization name
UDI-DI code
Reference / catalog number

Knife for Otis's dilator — Class I MDR by SUBAN Kéziműszer…

MD Atlas
SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on May 26, 2026

Knife for Otis's dilator

5996660Szo_szcs_tamp_taSU

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: 05996660034309
Reference / catalog number: RC-650-10

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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: Knife for Otis's dilator
UDI-DI code: 05996660034309
Basic UDI-DI: 5996660Szo_szcs_tamp_taSU
Reference / catalog number: RC-650-10
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)

L0509020199GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER

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.

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