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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

Empress Direct Ref. 10x0.2g IVA5… — Class IIa MDR

MD Atlas
Ivoclar Vivadent AG

EUDAMED last updated this device on Feb 10, 2026

Empress Direct Ref. 10x0.2g IVA5 Dentin

76152082AFILL009JS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ivoclar Vivadent AG
UDI-DI code: 07615208298277
Reference / catalog number: 627262AN

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Manufacturer information

Organization name: Ivoclar Vivadent AG
SRN: LI-MF-000000522
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Liechtenstein; available across 1 country total.

Country	On market since	Until
LiechtensteinPrimary placement		Still on market

Device identification

Trade name: Empress Direct Ref. 10x0.2g IVA5 Dentin
UDI-DI code: 07615208298277
Basic UDI-DI: 76152082AFILL009JS
Reference / catalog number: 627262AN
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: 10
Additional product description: Empress Direct Ref. 10x0.2g IVA5 Dentin
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.

Q01010103DENTAL RESTORATIVE COMPOSITES

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.