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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

1S5000 — Class I MDR by TRAYART srl

MD Atlas
TRAYART srl

EUDAMED last updated this device on Sep 2, 2025

1S5000

8050713021S5000HZ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TRAYART srl
UDI-DI code: 08050713020071
Reference / catalog number: 1S5000

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Manufacturer information

Organization name: TRAYART srl
SRN: IT-MF-000008850
Manufacturer status: Active

Critical warnings

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

CW010
In caso di contatto con astringenti contenenti solfati, possono verificarsi interazioni (inibizione della polimerizzazione), leggere attentamente le istruzioni del produttore
CW011
Controindicato per l'utilizzo in abbinamento a polieteri o siliconi per condensazione. Non miscelare ed evitare il contatto con guanti in lattice (si consiglia di utilizzare guanti in vinile, nitrile e lavare accuratamente le mani se sono stati indossati guanti in lattice). Non utilizzare verso pazienti con accertata o sospetta sensibilità ai siliconi poiché può essere causa di reazioni allergiche. Non ingerire, evitare il contatto con gli occhi.

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Market distribution

Primary placement in Italy; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08050713020071
Basic UDI-DI: 8050713021S5000HZ
Reference / catalog number: 1S5000
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

UDI-DI DataMatrix

Encoded

(01)08050713020071

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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.

Q01020102DENTAL IMPRESSION VINYLSILOXANS

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.