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Organization name
UDI-DI code
Reference / catalog number

N 113-8-0,5 — Class I MDR by MARTIKAN s.r.o.

MD Atlas
MARTIKAN s.r.o.

EUDAMED last updated this device on Apr 14, 2026

N 113-8-0,5

858602352KFXT

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MARTIKAN s.r.o.
UDI-DI code: 08586023524133
Reference / catalog number: N 113-8-0,5

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View device family (Basic UDI)

Manufacturer information

Organization name: MARTIKAN s.r.o.
SRN: SK-MF-000005834
Manufacturer status: Active

Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

2022-MDR/TD-003/ASupplemented
Technical documentationNotified body: 2265Expiry: Jul 20, 2027
2022-MDR/QS-003/ASupplemented
Quality management systemNotified body: 2265Expiry: Jul 20, 2027

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Slovakia; available across 2 countries total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market
Czechia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08586023524133
Basic UDI-DI: 858602352KFXT
Reference / catalog number: N 113-8-0,5
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: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

L159099ODONTOSTOMATOLOGY INSTRUMENTS, 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

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