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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

CU4U7116AG — Class IIa MDR by KEROX Ipari és…

MD Atlas
KEROX Ipari és Kereskedelmi Korlátolt Felelősségű Társaság

EUDAMED last updated this device on May 28, 2026

CU4U7116AG

5996612CUS00002F

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: KEROX Ipari és Kereskedelmi Korlátolt Felelősségű Társaság
UDI-DI code: 05996612011174
Reference / catalog number: CU4U7116AG

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View device family (Basic UDI)

Manufacturer information

Organization name: KEROX Ipari és Kereskedelmi Korlátolt Felelősségű Társaság
SRN: HU-MF-000031741
Manufacturer status: Active

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KEROX ZIRCOSTAR Pre-sintered zirconium-dioxide blank Ultra High TranslucentU4 unique shade 14 mm height Amann Girrbach 71 compatible S type5996612C3S0000LXOn the market

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement	Mar 19, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05996612011174
Basic UDI-DI: 5996612CUS00002F
Reference / catalog number: CU4U7116AG
Issuing entity: GS1

Classification

Risk category: Class IIa
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)05996612011174

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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.

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - 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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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.