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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

FS3-X-SO — Class I MDR by NTI-Kahla GmbH Rotary…

MD Atlas
NTI-Kahla GmbH Rotary Dental Instruments

EUDAMED last updated this device on May 19, 2025

FS3-X-SO

++E310DiaStFuellDF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NTI-Kahla GmbH Rotary Dental Instruments
UDI-DI code: +E310FS3XSO1
Reference / catalog number: FS3-X-SO

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Manufacturer information

Organization name: NTI-Kahla GmbH Rotary Dental Instruments
SRN: DE-MF-000009451
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: +E310FS3XSO1
Basic UDI-DI: ++E310DiaStFuellDF
Reference / catalog number: FS3-X-SO
Issuing entity: HIBCC

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: 2 x FS3-MX, mittlere Körnung, +E310FS3MX0 4 x FS3-FX, feine Körnung, +E310FS3FX0 4 x FS3-SFX, superfeine Körnung, +E310FS3SFX0
Additional information URL: https://www.nti.de/
Clinical sizes: Sortiment

EMDN nomenclature code(s)

L159019DENTAL FINISHING RASPS AND 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

FS2-F++E310DiaStFuellDFOn the market FS6-SO++E310DiaStFuellDFOn the market FS3-P-SO++E310DiaStFuellDFOn the market FS3-XP-SO++E310DiaStFuellDFOn the market FS6-F++E310DiaStFuellDFOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.