eudamed_udi Primary ID: 03770026739020

Baltique (UDI 03770026739020)

Manufactured by POLAAR

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Baltique (Model/Catalog Number: HAN1) is a medical device manufactured by POLAAR. This product is indexed under FDA Product Code / Category Classification Y060499 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: HAN1
Product Code / EMDN: Y060499
Device Name: baltique
Database Sync Date: 2026-08-09 16:29:51

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Baltique?

The registered manufacturer of record for Baltique is POLAAR.

What is the Primary UDI-DI identifier for Baltique?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03770026739020.

What classification code is assigned to this device?

This device is registered under product classification code Y060499.

Similar Classification Devices (Y060499)

Other Devices by POLAAR

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