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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

PROTASIL Thixo 50/50 — Class I MDR by Prevent Transformation

MD Atlas
Prevent Transformation

EUDAMED last updated this device on May 13, 2025

PROTASIL Thixo 50/50

376043076F730-30KN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Prevent Transformation
UDI-DI code: 03760430760000
Reference / catalog number: SISI302

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Manufacturer information

Organization name: Prevent Transformation
SRN: FR-MF-000047443
Manufacturer status: Active

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: PROTASIL Thixo 50/50
UDI-DI code: 03760430760000
Basic UDI-DI: 376043076F730-30KN
Reference / catalog number: SISI302
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: Silicone en rapport de mélange 1:1
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Hardness — 35 MU999
Blue
50 MU48

EMDN nomenclature code(s)

Q01020104DENTAL IMPRESSION SILICONES

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

This device is not currently linked to any other device.

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.