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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

MTI U04 — Class IIb MDR by MARTIKAN s.r.o.

MD Atlas
MARTIKAN s.r.o.

EUDAMED last updated this device on Jan 28, 2026

MTI U04

858602352MTIRL

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MARTIKAN s.r.o.
UDI-DI code: 08586023520500
Reference / catalog number: MTI U04

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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: 08586023520500
Basic UDI-DI: 858602352MTIRL
Reference / catalog number: MTI U04
Issuing entity: GS1

Classification

Risk category: Class IIb
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

UDI-DI DataMatrix

Encoded

(01)08586023520500

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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.

P01020101DENTAL IMPLANTS

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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