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Organization name
UDI-DI code
Reference / catalog number

SOPHY® SETTING INSTRUMENT — Class I MDR by SOPHYSA

MD Atlas
SOPHYSA

EUDAMED last updated this device on Dec 22, 2025

SOPHY® SETTING INSTRUMENT

376012413SAK000W4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOPHYSA
UDI-DI code: 03760124131963
Reference / catalog number: SAK-SI

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Manufacturer information

Organization name: SOPHYSA
SRN: FR-MF-000002870
Manufacturer status: Active

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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.
CW024
EUDAMED did not publish a description for this code.
CW027
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Hungary; available across 1 country total.

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

Device identification

Trade name: SOPHY® SETTING INSTRUMENT
UDI-DI code: 03760124131963
Basic UDI-DI: 376012413SAK000W4
Reference / catalog number: SAK-SI
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: Device for reading and adjusting the operating pressure of the Sophy® valve. To be used exclusively with the Instruments of a Sophy® Adjustment Kit (SAK) and according to its instructions for use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N0199ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM 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

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