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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

IRIS BY STARCK — Class I MDR by Scan4all

MD Atlas
Scan4all

EUDAMED last updated this device on Oct 27, 2025

IRIS BY STARCK

366412836641280000820UM

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Scan4all
UDI-DI code: 03664128000082
Reference / catalog number: NA

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Manufacturer information

Organization name: Scan4all
SRN: FR-MF-000003516
Manufacturer status: Active

Related devices

IRIS HANDPIECE36641283664128000006NPOn the market WOW3664128002000VTOn the market

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.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: IRIS BY STARCK
UDI-DI code: 03664128000082
Basic UDI-DI: 366412836641280000820UM
Reference / catalog number: NA
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: INTRAORAL CAMERA
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01020199DENTAL IMPRESSION MATERIALS - 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

UDI-PI traceability

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Expiration date
Manufacturing date
Serial number
Software identification