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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

Orban's tartar file,… — Class I MDR by SUBAN Kéziműszer…

MD Atlas
SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság

EUDAMED last updated this device on May 27, 2026

Orban's tartar file, double-ended, distal

5996660Fog.tom_kap_szon6S

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: 05996660064948
Reference / catalog number: UD-210-12

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View device family (Basic UDI)

Manufacturer information

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

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Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

No critical warnings reported for this device.

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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: Orban's tartar file, double-ended, distal
UDI-DI code: 05996660064948
Basic UDI-DI: 5996660Fog.tom_kap_szon6S
Reference / catalog number: UD-210-12
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05996660064948

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

L159009ODONTOSTOMATOLOGY SCALERS, 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

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