PolyLink (UDI 03700659400899)

Manufactured by SEFAM

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

Scannable UDI-DI Representation

Device Regulatory Overview

The PolyLink (Model/Catalog Number: M-116700) is a medical device manufactured by SEFAM. This product is indexed under FDA Product Code / Category Classification Z129012 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: M-116700
Product Code / EMDN: Z129012
Device Name: PolyLink
Database Sync Date: 2026-08-09 17:27:14

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 PolyLink?

The registered manufacturer of record for PolyLink is SEFAM.

What is the Primary UDI-DI identifier for PolyLink?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03700659400899.

What classification code is assigned to this device?

This device is registered under product classification code Z129012.

Similar Classification Devices (Z129012)

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