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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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Polaris® Valve Adjustment kit-2 — 3 UDI-DI variants, MDR (SOPHYSA)

MD Atlas
SOPHYSA

Data from EUDAMED, last updated May 19, 2026

Polaris® Valve Adjustment kit-2

376012413PAK000UV

3 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: SOPHYSA

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 376012413PAK000UV
Device name: Polaris® Valve Adjustment kit-2
Device model: PAK2
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Apr 1, 2025

Manufacturer & authorised representative

Manufacturer

Name: SOPHYSA
SRN: FR-MF-000002870
Country: France
Email: contact@sophysa.fr
Phone: +33169351055

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01JQR3Z8JA7WK5TPSVNYPTZVTJ

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

POLARIS® ADJUSTMENT KIT-2 Device for03760124131642
POLARIS® LOCATING INSTRUMENT-203760124131673
POLARIS® READING INSTRUMENT-203760124131666