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Organization name
UDI-DI code
Reference / catalog number

9125/3 — Class IIa MDR by Swissdentacare SA

MD Atlas
Swissdentacare SA

EUDAMED last updated this device on Apr 23, 2026

9125/3

764035775_Orthofile_Y3

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Swissdentacare SA
UDI-DI code: 07640357750789
Reference / catalog number: 9125/3

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Manufacturer information

Organization name: Swissdentacare SA
SRN: CH-MF-000016591
Manufacturer status: Active

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jul 19, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640357750789
Basic UDI-DI: 764035775_Orthofile_Y3
Reference / catalog number: 9125/3
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: 3
Additional product description: Swissdentacare 9125/3 Orthofile 125 µm two sides Pack of 3 pieces
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q01010199DENTAL RESTORATION DEVICES - OTHER
Q010499ORTHODONTIC 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

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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.