Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

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

MD Atlas
SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on May 26, 2026

Otis's dilator instument

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: 05996660034293
Reference / catalog number: RC-650-05

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

Abbey needle holder, 120 mm5996660FogokQ6On the market Abdominal and intestinal spatula, malleable, 30 mm, 410 mm5996660Kampo_hor_lapoc8LOn the market Abdominal and intestinal spatula, malleable, 40 mm, 410 mm5996660Kampo_hor_lapoc8LOn the market Abdominal and intestinal spatula, malleable, 50 mm, 410 mm5996660Kampo_hor_lapoc8LOn the market Abdominal and intestinal spatula, malleable, 60 mm, 410 mm5996660Kampo_hor_lapoc8LOn the market

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: Otis's dilator instument
UDI-DI code: 05996660034293
Basic UDI-DI: 5996660Szo_szcs_tamp_taSU
Reference / catalog number: RC-650-05
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